GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-1...
FDA Device Recall #Z-0812-2025 — Class II — November 25, 2024
Recall Summary
| Recall Number | Z-0812-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 281 units |
Product Description
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
Reason for Recall
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Distribution Pattern
Worldwide
Lot / Code Information
1) 5555000-12: UDI/DI none, Serial Numbers: 082407100532; UDI/DI to be provided, Serial Numbers: 082407160512; 2) 5555000-5: UDI/DI 840682115261, Serial Numbers: 1557XR0205, 352867XRA, 478765CDP1, 509962KV220, 601358OPTX220, 620421P3, 813872OPT3, SB2201700099WK; UDI/DI none, Serial Numbers: 479314220, 00028MOB12, 203694SB3, 205820DP1, 208666KDM, 209334OPT1, 210703M3, 240566PX2, 240964OPT1, 248465DP3, 256HHPORT2, 256HHPORT3, 256MHPORT1, 281MSL220, 281MSL2202, 305KEN220A, 306766DMOB2, 310680PORTDR2, 314251NAV7, 325574OPTITBD2, 330489DIGPORT, 333OPTI2, 333OPTI3, 333OPTI4, 352596OPT1, 352LEEDP1, 352VILDP1, 386FHODP3, 401OPTI1, 405636P2, 405636P240, 405752OPT1, 405752OPT2, 405752OPT4, 405DELCITY220, 407303OPTIMAX220, 408259AP6, 417347DPORT1, 417556P1, 417556P2, 417556P3, 419251DP1, 419251DP2, 419383DP1, 434654OPTIMA, 435CVXR220, 480MAYO220A, 501364OPTI1, 501364OPTI2, 509474DR1, 510437OPT1, 510727OPT3, 512SAMCSB, 513870DP1, 520TMCOPT2, 541426XR220, 559447OPT1, 559784OPT2, 561694OPT1, 561694OPT2, 561965DPORT5, 561965DPORT7, 573882DP1, 573882DP2, 573882DP3, 580421OPT1, 601288SB1, 601288SB2, 601288SB3, 601288SB6, 601928D220, 608364OPMX220, 613938XR3, 626457GEPORT1, 703369MDIG2, 703664M7, 706596SFP2, 706651DP, 715838DP2, 718206OPT240C, 718267DP5, 718670PTDR1, 720UCHSB7, 727848SB1, 731541SB1, 731541SB1A, 731541SB2, 731541SB3, 732324PA1, 732828DP11, 757388DP4, 770385220D1, 772468OPT1, 785776AMX220P1, 804281SMDM1, 806296OPTI220, 813302OPT3, 814837OPT, 815300M220C, 817927JPSXR220G, 817MCAXR220B, 828213DXP1, 828262P2202, 830RHHM1, 830RHHM2, 843847220B, 850325DP2, 863699OP220, 903886XR220, 905527XR220, 905845MOB4, 908685DP2, 909464220P1, 910615OPTIMA1, 910615OPTIMA2, 915521OPTIMA1, 915595OPT1, 940898XR220A, 940898XR240D, 985867M1, AXXXXX38, ORMCPORTA, ORMCPORTB, ORMCPORTC, ORMCPORTD, TAMXDRP03, WD0005, XR1036454WK5; 3) 5555000-6: UDI/DI 840682115261, Serial Numbers: 06051MOB06, 228809XR220, 228818XR220, 270798XR220B, 281KINGOPT3, 303450SB3, 303695SB3, 416323MOB3, 530888OPT1, 540981ODP3R, 540981ODP9, 615769OPTX220, 713529MDR220, 717782OPT4, 7982XR0192, 802775SB1, 813681OPT2, 918307OPT2, MHSWOPT2201, SA2513MM03, SB2201600071WK, SB2201700085WK, SJRO220P1, SJRO220P3, UTAHJAZZ, XR1864CO; UDI/DI none, Serial Numbers: 083007001584712, 0850070865, 0850070866, 0850070870, 0850070913, 0856070254, 0856070267, 0856070268, 091026DEMO2245, 10181MOB16, 140024RX14, 206598USB7, 209943OTP1, 214PH220G, 228575D220, 254HHSMOB1, 256429PORT2, 270688SB5, 281338BAPOR1, 281338CL221, 281338MDR220, 281348KWDM2, 281348KWDM3, 281KINGOPT1, 281MWB2202, 281MWB2203, 304255OPT220, 304623OPT220, 308865GSDP1, 309779RDIG2, 314525NAV15, 314525NAV16, 318675PW1, 318675PW2, 318769RDPT1, 318769RDPT2, 330480DP1, 330480DP2, 330480DP3, 330480DP4, 370OPTI1, 409938DR1220, 412232DMX2, 412372DMX1, 412647DMX2, 419291DP4, 419893DP1, 423493DP2, 432685OPT2, 434799GE220, 469764XR220H, 504454XR221, 504785MD1, 504873TMD8, 513732DP1, 563742NDIG1, 574267XR220, 586263DP1, 586493DP1, 601798D220, 614257DP4, 615284STMDR2, 615284STMDR3, 615316DP1, 615342DP1, 615391SUR, 702SIEXR221, 702SIEXR226, 713359BSDM3, 713440DP1, 713441OPCDX1, 714966GEPORT2, 720UCHSB9, 740592OPTIMA2, 77522MOB14, 801479SB2, 810342DP2, 817255NHXR220A, 817HUG220C, 817PLAZA220A, 817SAGERXR220A, 865541DP2, 865545DP1, 865545DP3, 903CSM222, 904OPMCDP3, 914737PORTWK3, 915577XR220, 916UCDAMXDR23, 916UCDAMXDR27, 918579OPT2, 919774DIGPRT, 928757XR222, 936539DM1, 936539DM2, 949517DR1, 949764DR2, 949764DR3, 949764DR4, 972420XR220B, 972420XR220C, 972566XR220F, 979MGXR220, LLPM220P1, MHKOPT220, SA1056MM06, SA2161MM04, XR1031657WK8, ZA1067RX30; 4) A0659PB: UDI/DI 840682115261, Serial Numbers: 702880EROP1; UDI/DI none, Serial Numbers: 206598USB6; 5) to be provided: UDI/DI none, Serial Numbers: 240826OPT1, 772SRDP1, 817HUG220B 860545SB2A; UDI/DI to be provided, Serial Numbers: 907852OPT22019, SA1075MM04.
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|---|---|---|---|
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| Z-2149-2026 | Class II | Revolution Ascend, computed tomography, Model N... | Mar 26, 2026 |
| Z-2150-2026 | Class II | Revolution CT, x-ray computed tomography, Model... | Mar 26, 2026 |
| Z-2153-2026 | Class II | Revolution CT ES, X-ray Computed Tomography, Mo... | Mar 26, 2026 |
| Z-2151-2026 | Class II | Revolution Apex Elite, X-ray Computed Tomograph... | Mar 26, 2026 |
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.