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GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 20384...

FDA Device Recall #Z-1486-2025 — Class II — February 19, 2025

Recall Summary

Recall Number Z-1486-2025
Classification Class II — Moderate risk
Date Initiated February 19, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare
Location Chicago, IL
Product Type Devices
Quantity 633 units

Product Description

GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

Reason for Recall

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Distribution Pattern

Worldwide distribution.

Lot / Code Information

Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI UDI Not Required, System ID 520855CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103987-1-Centricity CA1000-00102841, UDI UDI Not Required, System ID 928537CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9990-1-Centricity CA1000-00101135, UDI UDI not required, System ID 661327CWS01; Model/Catalog/Code # 2038437-001, Installed Product ID 10318-1-Centricity CA1000-00105877, UDI UDI not required, System ID 818397CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10994-1-Centricity CA1000-00102387, UDI UDI Not required, System ID 909464CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102131-1-Centricity CA1000-00105886, UDI UDI not required, System ID 818409CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4161-1-Centricity CA1000-00105894, UDI UDI Not Required, System ID 818502CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103743-1-Centricity CA1000-00099665, UDI UDI Not Required, System ID 559582CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4408-2-Centricity CA1000-00101725, UDI UDI not required, System ID 714843CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 4532-4-Centricity CA1000-00107356, UDI UDI Not Required, System ID 310673CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4009-2-Centricity CA1000-00100791, UDI UDI not required, System ID 619260CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1354-8-Centricity CA1000-00102389, UDI UDI not required, System ID 909558CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9927-2-Centricity CA1000-00099762, UDI UDI not required, System ID 562491CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11299-9-Centricity CA1000-00109567, UDI UDI Not Required, System ID SVMCA6; Model/Catalog/Code # 2038437-001, Installed Product ID 4446-2-Centricity CA1000-00107805, UDI (01)00840682125260(10)20P14H2038437016, System ID 323726CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103447-1-Centricity CA1000-22271916, UDI (01)00840682125260(10)20P14J2038437016, System ID CALIFORNIA22271916; Model/Catalog/Code # 2038437-001, Installed Product ID 100256-3-Centricity CA1000-00101156, UDI (01)00840682125260(10)20P14J2038437016, System ID 661948CA1RSW; Model/Catalog/Code # 2038437-001, Installed Product ID 11169-1-Centricity CA1000-00102586, UDI UDI not required, System ID 916225CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1223-17-Centricity CA1000-00106365, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 858554CA1SW14; Model/Catalog/Code # 2038437-001, Installed Product ID 1845-2-Centricity CA1000-00100829, UDI UDI not required, System ID 619691CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 2195-12-Centricity CA1000-16385905, UDI UDI Not Required, System ID UCLAMC16385905; Model/Catalog/Code # 2038437-001, Installed Product ID 9985-1-Centricity CA1000-00106974, UDI UDI not required, System ID 303695CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103533-5-Centricity CA1000-02299486, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID BOULDERCO02299486; Model/Catalog/Code # 2038437-001, Installed Product ID 10617-1-Centricity CA1000-00107034, UDI UDI not required, System ID 303839CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100385-1-Centricity CA1000-00106873, UDI UDI not required, System ID 303320CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10482-1-Centricity CA1000-00103250, UDI UDI not required, System ID 970764CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10841-1-Centricity CA1000-00106998, UDI UDI not required, System ID 303788CVIT5; Model/Catalog/Code # 2038437-001, Installed Product ID 9900-1-Centricity CA1000-00106902, UDI UDI not required, System ID 303451CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 2386-2-Centricity CA1000-00116051, UDI UDI not required, System ID 203276CA1000RV1; Model/Catalog/Code # 2038437-001, Installed Product ID 101581-1-Centricity CA1000-00095981, UDI UDI not required, System ID 202745CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4698-3-Centricity CA1000-00108747, UDI UDI not required, System ID MCTHCA10001; Model/Catalog/Code # 2038437-001, Installed Product ID 101194-2-Centricity CA1000-00103078, UDI UDI not required, System ID 941792HCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10298-1-Centricity CA1000-00105482, UDI UDI not required, System ID 813681CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10298-1-Centricity CA1000-00105491, UDI UDI not required, System ID 813681CA1SW19; Model/Catalog/Code # 2038437-001, Installed Product ID 11209-1-Centricity CA1000-00095905, UDI UDI not required, System ID 0004053422A; Model/Catalog/Code # 2038437-001, Installed Product ID 10218-4-Centricity CA1000-00108483, UDI UDI not required, System ID FWBCA1005; Model/Catalog/Code # 2038437-001, Installed Product ID 10218-2-Centricity CA1000-00095912, UDI UDI not required, System ID FWBCA14; Model/Catalog/Code # 2038437-001, Installed Product ID 103638-1-Centricity CA1000-00107955, UDI UDI not required, System ID 352331CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10849-3-Centricity CA1000-00107230, UDI UDI Not Required, System ID 305364CA2100; Model/Catalog/Code # 2038437-001, Installed Product ID 103203-1-Centricity CA1000-22144957, UDI (01)00840682125260(10)20P14J2038437016, System ID BIHT22144957; Model/Catalog/Code # 2038437-001, Installed Product ID 10458-5-Centricity CA1000-00102189, UDI UDI not required, System ID 904399HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11208-2-Centricity CA1000-00103172, UDI UDI not required, System ID 954974CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101427-1-Centricity CA1000-00104669, UDI UDI not required, System ID 727848HCA1SW7; Model/Catalog/Code # 2038437-001, Installed Product ID 10264-1-Centricity CA1000-00095914, UDI UDI not required, System ID 850769HCA1SW11; Model/Catalog/Code # 2038437-001, Installed Product ID 101180-1-Centricity CA1000-00104672, UDI UDI not required, System ID 727863CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103577-2-Centricity CA1000-00104941, UDI UDI not required, System ID 772581CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 104179-1-Centricity CA1000-00104625, UDI UDI Not required, System ID 727521CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103788-1-Centricity CA1000-00104637, UDI UDI not required, System ID 727521OPCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11639-1-Centricity CA1000-00104600, UDI UDI not required, System ID 727384CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10475-1-Centricity CA1000-00097981, UDI UDI not required, System ID 407321SWCA1; Model/Catalog/Code # 2038437-001, Installed Product ID 11041-1-Centricity CA1000-00103047, UDI UDI Not Required, System ID 941342CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11743-1-Centricity CA1000-00095913, UDI (01)00840682125260(10)20P14H2038437016, System ID 0004275549A; Model/Catalog/Code # 2038437-001, Installed Product ID 11743-1-Centricity CA1000-01973685, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 850325HCA1SW5; Model/Catalog/Code # 2038437-001, Installed Product ID 13367-1-Centricity CA1000-02041150, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID HCAE02041150; Model/Catalog/Code # 2038437-001, Installed Product ID 100620-13-Centricity CA1000-00163680, UDI UDI not required, System ID 813885HCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1657-7-Centricity CA1000-00105550, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 813971CA10003; Model/Catalog/Code # 2038437-001, Installed Product ID 10292-2-Centricity CA1000-00104678, UDI UDI Not Required, System ID 727942CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100115-1-Centricity CA1000-00101433, UDI UDI Not Required, System ID 706651HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3901-2-Centricity CA1000-00101421, UDI UDI not required, System ID 706596CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10147-2-Centricity CA1000-22155331, UDI (01)00840682125260(10)20P14J2038437016, System ID CRH522155331; Model/Catalog/Code # 2038437-001, Installed Product ID 9847-2-Centricity CA1000-00108204, UDI UDI not required, System ID 404501CA1SW1A; Model/Catalog/Code # 2038437-001, Installed Product ID 10209-1-Centricity CA1000-00098680, UDI UDI Not Required, System ID 478274CA1SW100; Model/Catalog/Code # 2038437-001, Installed Product ID 11047-6-Centricity CA1000-00101185, UDI UDI not required, System ID 678957CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 11047-6-Centricity CA1000-00101186, UDI UDI not required, System ID 678957CA2; Model/Catalog/Code # 2038437-001, Installed Product ID 3929-2-Centricity CA1000-00105388, UDI UDI not required, System ID 808485CA1SW2; Model/Catalog/Code # 2038437-001, Installed Product ID 1458-6-Centricity CA1000-00107439, UDI UDI Not Required, System ID 312RUSH1CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 1566-4-Centricity CA1000-00102050, UDI UDI not required, System ID 877453CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1566-4-Centricity CA1000-00102051, UDI UDI not required, System ID 877453CA1SW2; Model/Catalog/Code # 2038437-001, Installed Product ID 101349-2-Centricity CA1000-00109702, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID UICCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 101349-2-Centricity CA1000-22176245, UDI (01)00840682125260(10)20P14J2038437016, System ID UIMC22176245; Model/Catalog/Code # 2038437-001, Installed Product ID 101454-1-Centricity CA1000-00101519, UDI UDI Not Required, System ID 708202CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10691-2-Centricity CA1000-00096590, UDI UDI Not required, System ID 217258CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11367-1-Centricity CA1000-00101569, UDI UDI not required, System ID 708681CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10251-3-Centricity CA1000-00100783, UDI UDI not required, System ID 618241CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100086-1-Centricity CA1000-00107335, UDI UDI not required, System ID 309CA1000SW4; Model/Catalog/Code # 2038437-001, Installed Product ID 1250-1-Centricity CA1000-00101545, UDI UDI Not Required, System ID 708361CA1000SW; Model/Catalog/Code # 2038437-001, Installed Product ID 1237-1-Centricity CA1000-00103189, UDI UDI Not Required, System ID 956544CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3832-1-Centricity CA1000-00105463, UDI UDI not required, System ID 812858CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 8637-1-Centricity CA1000-00107663, UDI UDI not required, System ID 317621CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3864-3-Centricity CA1000-00105445, UDI (01)00840682125260(10)20P14J2038437016, System ID 812482CA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 102796-1-Centricity CA1000-00104871, UDI UDI not required, System ID 765671CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10943-1-Centricity CA1000-00107645, UDI (01)00840682125260(10)20P14F2038437016, System ID 316962HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103613-1-Centricity CA1000-00107629, UDI UDI not required, System ID 316858HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103897-1-Centricity CA1000-00097067, UDI (01)00840682125260(10)20P14J2038437016, System ID 270465CA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 102600-3-Centricity CA1000-00100351, UDI UDI not required, System ID 606439CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100435-3-Centricity CA1000-00100367, UDI UDI Not Required, System ID 606759CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 10380-2-Centricity CA1000-00100361, UDI (01)00840682125260(10)20P14J2038437016, System ID 606679CA1K1; Model/Catalog/Code # 2038437-001, Installed Product ID 10637-1-Centricity CA1000-00107698, UDI UDI not required, System ID 318473CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4643-3-Centricity CA1000-00107915, UDI UDI Not Required, System ID 337289CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10845-1-Centricity CA1000-00098992, UDI UDI Not Required, System ID 504380CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102718-1-Centricity CA1000-00107677, UDI UDI not required, System ID 318254CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101572-1-Centricity CA1000-00107675, UDI UDI Not Required, System ID 318221CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3104-3-Centricity CA1000-00100765, UDI UDI not required, System ID 617754CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103916-2-Centricity CA1000-00099172, UDI UDI Not Required, System ID 508335CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10488-1-Centricity CA1000-00099175, UDI UDI Not required, System ID 508383CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 102719-1-Centricity CA1000-00098281, UDI UDI not required, System ID 413748CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3720-3-Centricity CA1000-00098647, UDI UDI not required, System ID 443481CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10996-4-Centricity CA1000-00096899, UDI (01)00840682125260(10)20P14J2038437016, System ID 248360CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 13399-8-Centricity CA1000-17322532, UDI (01)00840682125260(10)2.0SP14A2038437016C, System ID VANA17322532; Model/Catalog/Code # 2038437-001, Installed Product ID 10516-1-Centricity CA1000-22189501, UDI (01)00840682125260(10)20P14J2038437016, System ID MMC1922189501; Model/Catalog/Code # 2038437-001, Installed Product ID 13370-4-Centricity CA1000-20698703, UDI (01)00840682125260(10)20P14J2038437016, System ID ABBT20698703; Model/Catalog/Code # 2038437-001, Installed Product ID 100796-1-Centricity CA1000-00100559, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 612638CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10159-3-Centricity CA1000-00104275, UDI UDI Not Required, System ID W128CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1651-1-Centricity CA1000-00099865, UDI UDI not required, System ID 573761CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101536-1-Centricity CA1000-00105734, UDI UDI Not Required, System ID 816861CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 1651-14-Centricity CA1000-00104265, UDI UDI not required, System ID W113CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11281-1-Centricity CA1000-00104246, UDI UDI not required, System ID W022CA001; Model/Catalog/Code # 2038437-001, Installed Product ID 11445-3-Centricity CA1000-00109178, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID S011PCA1REV; Model/Catalog/Code # 2038437-001, Installed Product ID 11445-7-Centricity CA1000-20025014, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID SHSLMHC20025014; Model/Catalog/Code # 2038437-001, Installed Product ID 11445-2-Centricity CA1000-00104209, UDI UDI Not Required, System ID W001CA1SW10; Model/Catalog/Code # 2038437-001, Installed Product ID 3675-3-Centricity CA1000-00099941, UDI UDI Not Required, System ID 601364CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11243-3-Centricity CA1000-00099982, UDI UDI Not Required, System ID 601883CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11243-3-Centricity CA1000-00099983, UDI UDI Not Required, System ID 601883CA1SW2; Model/Catalog/Code # 2038437-001, Installed Product ID 10933-2-Centricity CA1000-00105927, UDI UDI not required, System ID 828262CA1000SW; Model/Catalog/Code # 2038437-001, Installed Product ID 3725-1-Centricity CA1000-22247761, UDI (01)00840682125260(10)20P14J2038437016, System ID CTV22247761; Model/Catalog/Code # 2038437-001, Installed Product ID 10196-1-Centricity CA1000-00100125, UDI UDI not required, System ID 603669CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4696-2-Centricity CA1000-00100128, UDI UDI Not Required, System ID 603882CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10610-1-Centricity CA1000-00100082, UDI UDI not required, System ID 603433CA1SW4; Model/Catalog/Code # 2038437-001, Installed Product ID 3820-1-Centricity CA1000-00104711, UDI UDI not required, System ID 732294CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 104070-1-Centricity CA1000-00103474, UDI UDI not required, System ID 973956CA10001S; Model/Catalog/Code # 2038437-001, Installed Product ID 103432-1-Centricity CA1000-00099060, UDI (01)00840682125260(10)20P14J2038437016, System ID 505848CASFT; Model/Catalog/Code # 2038437-001, Installed Product ID 3865-2-Centricity CA1000-00099049, UDI UDI Not Required, System ID 505522CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10513-2-Centricity CA1000-00101237, UDI UDI not required, System ID 702255CA10001; Model/Catalog/Code # 2038437-001, Installed Product ID 11239-1-Centricity CA1000-00104995, UDI UDI not required, System ID 775982CA2100; Model/Catalog/Code # 2038437-001, Installed Product ID 4029-47-Centricity CA1000-00099399, UDI UDI not required, System ID 516562CASW7; Model/Catalog/Code # 2038437-001, Installed Product ID 10732-1-Centricity CA1000-00100957, UDI UDI not required, System ID 631968CARR1; Model/Catalog/Code # 2038437-001, Installed Product ID 1196-58-Centricity CA1000-00104474, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 718920CA1SW10; Model/Catalog/Code # 2038437-001, Installed Product ID 104038-1-Centricity CA1000-00101887, UDI UDI Not Required, System ID 718246CA1HW; Model/Catalog/Code # 2038437-001, Installed Product ID 102250-1-Centricity CA1000-00104390, UDI UDI not required, System ID 718270CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4029-9-Centricity CA1000-00100970, UDI UDI not required, System ID 631968SSCA1; Model/Catalog/Code # 2038437-001, Installed Product ID 4374-3-Centricity CA1000-00106119, UDI UDI Not required, System ID 845343CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4029-8-Centricity CA1000-00099376, UDI UDI not required, System ID 516562AI10002; Model/Catalog/Code # 2038437-001, Installed Product ID 4029-8-Centricity CA1000-00104421, UDI UDI not required, System ID 718470CASW10; Model/Catalog/Code # 2038437-001, Installed Product ID 4029-51-Centricity CA1000-14194765, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID NSLI14194765; Model/Catalog/Code # 2038437-001, Installed Product ID 102193-2-Centricity CA1000-00099495, UDI UDI not required, System ID 518382CA10001; Model/Catalog/Code # 2038437-001, Installed Product ID 102193-2-Centricity CA1000-22157802, UDI (01)00840682125260(10)20P14J2038437016, System ID ELLISHOSP22157802; Model/Catalog/Code # 2038437-001, Installed Product ID 102238-1-Centricity CA1000-00106055, UDI UDI Not Required, System ID 843668CA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 1207-8-Centricity CA1000-00105459, UDI (01)00840682125260(10)20P14J2038437016, System ID 8125551CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10240-2-Centricity CA1000-00104793, UDI (01)00840682125260(10)20P14J2038437016, System ID 740454CA1SW3; Model/Catalog/Code # 2038437-001, Installed Product ID 102169-1-Centricity CA1000-00099885, UDI UDI not required, System ID 580421VVCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 103361-1-Centricity CA1000-00097922, UDI UDI not required, System ID 405ERMCCA1; Model/Catalog/Code # 2038437-001, Installed Product ID 1475-4-Centricity CA1000-00097935, UDI UDI not required, System ID 405STAC1000SW6; Model/Catalog/Code # 2038437-001, Installed Product ID 1475-1-Centricity CA1000-00097938, UDI UDI Not Required, System ID 405STACA041; Model/Catalog/Code # 2038437-001, Installed Product ID 10743-4-Centricity CA1000-00551324, UDI UDI not required, System ID 405272CA1000RV1; Model/Catalog/Code # 2038437-001, Installed Product ID 1467-3-Centricity CA1000-00102747, UDI UDI not required, System ID 918744CA1SW5; Model/Catalog/Code # 2038437-001, Installed Product ID 103440-1-Centricity CA1000-00099656, UDI UDI Not Required, System ID 54174CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1999-7-Centricity CA1000-00098806, UDI UDI not required, System ID 484488CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103653-1-Centricity CA1000-22251392, UDI (01)00840682125260(10)20P14J2038437016, System ID ASSOCIATIO22251392; Model/Catalog/Code # 2038437-001, Installed Product ID 1999-19-Centricity CA1000-00101907, UDI UDI not required, System ID 861MCACR; Model/Catalog/Code # 2038437-001, Installed Product ID 100254-1-Centricity CA1000-17594352, UDI (01)00840682125260(10)20P14J2038437016, System ID STMARYME17594352; Model/Catalog/Code # 2038437-001, Installed Product ID 1581-4-Centricity CA1000-00101780, UDI UDI not required, System ID 717270CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101079-1-Centricity CA1000-00099788, UDI (01)00840682125260(10)20P14J2038437016, System ID 570522CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3719-1-Centricity CA1000-00104553, UDI UDI not required, System ID 724728HVCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4299-2-Centricity CA1000-00096454, UDI (01)00840682125260(10)20P14J2038437016, System ID 215335CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11673-4-Centricity CA1000-00096463, UDI UDI not required, System ID 215453CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102401-1-Centricity CA1000-00101815, UDI UDI not required, System ID 717765CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101583-1-Centricity CA1000-00099808, UDI UDI not required, System ID 570824CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10863-2-Centricity CA1000-00106092, UDI UDI Not Required, System ID 843797CHL1; Model/Catalog/Code # 2038437-001, Installed Product ID 101518-1-Centricity CA1000-00095910, UDI (01)00840682125260(10)20P14J2038437016, System ID 0004190048A; Model/Catalog/Code # 2038437-001, Installed Product ID 10992-2-Centricity CA1000-00106056, UDI UDI Not Required, System ID 843674CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101512-3-Centricity CA1000-00106083, UDI UDI not required, System ID 843789CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10603-1-Centricity CA1000-00105154, UDI UDI Not Required, System ID 803329CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11305-1-Centricity CA1000-00106029, UDI UDI not required, System ID 843552CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11305-1-Centricity CA1000-00106030, UDI UDI not required, System ID 843552HCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10109-1-Centricity CA1000-00106302, UDI UDI Not Required, System ID 850764HCA1SW6; Model/Catalog/Code # 2038437-001, Installed Product ID 3949-4-Centricity CA1000-00101994, UDI UDI not required, System ID 865541CA1K1; Model/Catalog/Code # 2038437-001, Installed Product ID 10590-1-Centricity CA1000-00102019, UDI UDI not required, System ID 865693CA139; Model/Catalog/Code # 2038437-001, Installed Product ID 3949-6-Centricity CA1000-00098555, UDI UDI not required, System ID 423586CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100248-1-Centricity CA1000-00102862, UDI UDI not required, System ID 928758CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11011-3-Centricity CA1000-00101986, UDI UDI Not required, System ID 865481CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11011-3-Centricity CA1000-00101988, UDI UDI not required, System ID 865481CA1SW3; Model/Catalog/Code # 2038437-001, Installed Product ID 10433-3-Centricity CA1000-00105822, UDI UDI not required, System ID 817472CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10914-2-Centricity CA1000-00097121, UDI UDI not required, System ID 281325CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9859-80-Centricity CA1000-20100489, UDI (01)00840682125260(10)20P14M2038437016, System ID HH1020100489; Model/Catalog/Code # 2038437-001, Installed Product ID 100085-4-Centricity CA1000-00103005, UDI UDI not required, System ID 940384CA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 10439-1-Centricity CA1000-00096398, UDI UDI not required, System ID 214420HCA1SW5; Model/Catalog/Code # 2038437-001, Installed Product ID 10140-2-Centricity CA1000-00103680, UDI UDI not required, System ID BACATH50; Model/Catalog/Code # 2038437-001, Installed Product ID 10442-1-Centricity CA1000-00103288, UDI UDI not required, System ID 972556CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3677-2-Centricity CA1000-00104366, UDI (01)00840682125260(10)20P14J2038437016, System ID WRCAREVIEWSW; Model/Catalog/Code # 2038437-001, Installed Product ID 10168-1-Centricity CA1000-00103895, UDI UDI not required, System ID DRCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 104089-1-Centricity CA1000-00105850, UDI UDI not required, System ID 817639HCA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 11227-1-Centricity CA1000-00105785, UDI UDI not required, System ID 817347CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10948-1-Centricity CA1000-00097149, UDI UDI Not required, System ID 281588CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103744-1-Centricity CA1000-00097146, UDI UDI not required, System ID 281579CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103656-1-Centricity CA1000-00105352, UDI (01)00840682125260(10)20P14J2038437016, System ID 806687CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 2163-3-Centricity CA1000-00103277, UDI UDI not required, System ID 972548HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9898-3-Centricity CA1000-00105744, UDI UDI Not Required, System ID 817225CA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 3953-2-Centricity CA1000-00109631, UDI (01)00840682125260(10)20P14J2038437016, System ID THHBPEPCARR2; Model/Catalog/Code # 2038437-001, Installed Product ID 10441-1-Centricity CA1000-00095903, UDI UDI not required, System ID 0004020010A; Model/Catalog/Code # 2038437-001, Installed Product ID 4575-1-Centricity CA1000-00102111, UDI UDI not required, System ID 903885CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3871-5-Centricity CA1000-00102105, UDI UDI Not Required, System ID 903595CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 105534-1-Centricity CA1000-00108074, UDI UDI Not Required, System ID 361788CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102133-1-Centricity CA1000-00105849, UDI UDI not required, System ID 817599CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10811-1-Centricity CA1000-01893386, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID CAMC01893386; Model/Catalog/Code # 2038437-001, Installed Product ID 2565-5-Centricity CA1000-00100411, UDI UDI Not Required, System ID 608775CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 102098-1-Centricity CA1000-00098301, UDI UDI not required, System ID 414447CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 106175-1-Centricity CA1000-22219327, UDI (01)00840682125260(10)20P14J2038437016, System ID MILWAUKEE22219327; Model/Catalog/Code # 2038437-001, Installed Product ID 103367-1-Centricity CA1000-00096997, UDI UDI not required, System ID 262687CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103742-1-Centricity CA1000-00107068, UDI UDI not required, System ID 304347CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 10783-1-Centricity CA1000-00107072, UDI UDI not required, System ID 304424CASSASW; Model/Catalog/Code # 2038437-001, Installed Product ID 080041-Centricity CA1000-00071765, UDI UDI Not required, System ID 080041ST03; Model/Catalog/Code # 2038437-001, Installed Product ID 080041-Centricity CA1000-00059699, UDI UDI Not required, System ID 080041ST02; Model/Catalog/Code # 2038437-001, Installed Product ID 290472-Centricity CA1000-20091941, UDI (01)00840682125260(10)20P14E2038437016, System ID HCIT4753340CA; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-02181400, UDI UDI Not Required, System ID 604875CA1000SW11; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667187, UDI UDI Not Required, System ID 604875CA1000SW01; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667188, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 604875CA1000SW02; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667189, UDI UDI Not Required, System ID 604875CA1000SW03; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667190, UDI UDI Not Required, System ID 604875CA1000SW04; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667191, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 604875CA1000SW05; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667192, UDI UDI Not Required, System ID 604875CA1000SW06; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667193, UDI UDI Not Required, System ID 604875CA1000SW07; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667194, UDI UDI Not Required, System ID 604875CA1000SW08; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667195, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 604875CA1000SW09; Model/Catalog/Code # 2038437-001, Installed Product ID 282519-Centricity CA1000-00667196, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 604875CA1000SW10; Model/Catalog/Code # 2038437-001, Installed Product ID 283039-Centricity CA1000-02189544, UDI (01)00840682125260(10)20P14M2038437016, System ID 613548AI1000; Model/Catalog/Code # 2038437-001, Installed Product ID 283039-Centricity CA1000-02189546, UDI (01)00840682125260(10)20P14M2038437016, System ID 613548CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 283007-Centricity CA1000-00828863, UDI UDI Not Required, System ID 905895CA1000A; Model/Catalog/Code # 2038437-001, Installed Product ID 282920-Centricity CA1000-21349651, UDI (01)00840682125260(10)20P14M2038437016, System ID 416461CA1000A; Model/Catalog/Code # 2038437-001, Installed Product ID 282920-Centricity CA1000-21349652, UDI (01)00840682125260(10)20P14M2038437016, System ID 416461CA1000B; Model/Catalog/Code # 2038437-001, Installed Product ID 282920-Centricity CA1000-21349653, UDI (01)00840682125260(10)20P14M2038437016, System ID 416461CA1000C; Model/Catalog/Code # 2038437-001, Installed Product ID 282913-1342026-Centricity CA1000-00604941, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 416360CA10001sw; Model/Catalog/Code # 2038437-001, Installed Product ID 282913-1342026-Centricity CA1000-00604942, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 416360CA10002sw; Model/Catalog/Code # 2038437-001, Installed Product ID 282913-1342026-Centricity CA1000-00604943, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 416360CA10003sw; Model/Catalog/Code # 2038437-001, Installed Product ID 282913-1342026-Centricity CA1000-00604945, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 416360CA10004sw; Model/Catalog/Code # 2038437-001, Installed Product ID 282913-1342026-Centricity CA1000-00604946, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 416360CA10005s

Other Recalls from GE Healthcare

Recall # Classification Product Date
Z-1475-2026 Class II GE Healthcare Centricity Universal Viewer Zero ... Jan 16, 2026
Z-1487-2025 Class II GE Healthcare Centricity Centricity PACS-IW wit... Feb 19, 2025
Z-1484-2025 Class II GE Healthcare Centricity PACS-IW (PACS-IW), Mod... Feb 19, 2025
Z-1483-2025 Class II GE Healthcare Centricity Universal Viewer (UV),... Feb 19, 2025
Z-1485-2025 Class II GE Healthcare Centricity Radiology RA600 (RA600... Feb 19, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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