GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; ...
FDA Device Recall #Z-0889-2025 — Class II — December 18, 2024
Recall Summary
| Recall Number | Z-0889-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 18, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Location | Tirat Carmel |
| Product Type | Devices |
| Quantity | 116 units |
Product Description
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
Reason for Recall
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Distribution Pattern
Worldwide
Lot / Code Information
1) 5376204-15: UDI/DI 00840682145503, System ID 502629NMGD, Serial Number NT2UG2100002BH; UDI/DI 00840682117869, System ID 509455BRIVO, Serial Number NT24G1700010BH, UDI/DI N/A, System ID 248544D630, Serial Number NT2QG1900003BH\NT2UG2100001BH. 2) H2401MA: UDI/DI Not Available, System ID 501552D615, Serial Number NT24G1600023; UDI/DI Not Available, System ID 100035454149, Serial Number T2CG15015/100035454149; UDI/DI Not Available, System ID 337643NM, Serial Number NT24G1600021; UDI/DI Not Available, System ID 718963B615, Serial Number NT24G1700009; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1600020; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1700010; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1800001; UDI/DI (01)00840682117869(11)17060021NT24G1700003BH, System ID NM6583AR, Serial Number NT24G1700003; UDI/DI (01)00840682117869(11)17090021NT24G1700006BH, System ID NT24G1700006BH, Serial Number NT24G1700006; UDI/DI (01)00840682117869(11)17080021NT24G1700004BH, System ID NT24G1700004BH, Serial Number NT24G1700004; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1700008; UDI/DI Not Available, System ID CS1052NM10, Serial Number T2CG15010/166BH9; UDI/DI Not Available, System ID DK1043NM01, Serial Number T2CG15009/163BH6; UDI/DI Not Available, System ID EG2559NM01, Serial Number NT24G1700001; UDI/DI Not Available, System ID M4143529, Serial Number T2CG16018/187BH5; UDI/DI Not Available, System ID 083026108252217, Serial Number T2CG16019/232BH9; UDI/DI Not Available, System ID 083026108252217, Serial Number NT24G1700005; UDI/DI Not Available, System ID 083026861420919, Serial Number NT24G1800007; UDI/DI Not Available, System ID Not Available, Serial Number T2CG13006/127BH1; UDI/DI Not Available, System ID 083026862894721, Serial Number NT24G1800005; UDI/DI Not Available, System ID 083026861823315, Serial Number T2CG15014/177BH6; UDI/DI Not Available, System ID 083026208602217, Serial Number NT24G1700002/227BH9; UDI/DI Not Available, System ID 083026285354315, Serial Number T2CG15013/176BH8; UDI/DI Not Available, System ID 083026040018413, Serial Number T2CG12003/116BH4; UDI/DI Not Available, System ID Not Available, Serial Number T2CG11002; UDI/DI Not Available, System ID Not Available, Serial Number T2CG12004; UDI/DI Not Available, System ID Not Available, Serial Number T2CG14007; UDI/DI Not Available, System ID PK1267NM01, Serial Number T2CG11001/84BH4; UDI/DI Not Available, System ID 1557MI0001, Serial Number T2CG15012/170BH1; UDI/DI Not Available, System ID SA2514NM01, Serial Number NT24G1600022; UDI/DI Not Available, System ID ZA2757NM01, Serial Number T2CG16016/182BH6; UDI/DI (01)00840682117869(11)171100NT24G1700007BH, System ID ZA3066NM01, Serial Number NT24G1700007; UDI/DI Not Available, System ID ZA2223NM02, Serial Number T2CG15008/161BH0; UDI/DI Not Available, System ID ZA3209NM01, Serial Number NT24G1800003; UDI/DI Not Available, System ID 475290NU02, Serial Number NT24G1800002; UDI/DI Not Available, System ID 266340NU01, Serial Number T2CG16017/185BH9. 3) H3100TA: UDI/DI N/A, System ID 478765BRIVO1, Serial Number 24003; UDI/DI N/A, System ID 515239MGB615, Serial Number 24022; UDI/DI N/A, System ID 606242B615, Serial Number 24018; UDI/DI N/A, System ID 859879B615, Serial Number 24053; UDI/DI N/A, System ID 337788BR615, Serial Number 24035; UDI/DI N/A, System ID 248898B615, Serial Number 24056; UDI/DI N/A, System ID 651241DSC615, Serial Number 24037; UDI/DI N/A, System ID 406222LN615, Serial Number 24001; UDI/DI N/A, System ID B615GEMINI01, Serial Number 24058; UDI/DI N/A, System ID Not Available, Serial Number 24052; UDI/DI N/A, System ID 702304NM615, Serial Number 24013; UDI/DI N/A, System ID 607762B615, Serial Number 24030; UDI/DI N/A, System ID 513636B615, Serial Number 24059; UDI/DI N/A, System ID 937208B615, Serial Number 24070; UDI/DI N/A, System ID 405456NM615, Serial Number 24004; UDI/DI N/A, System ID 806665NM615, Serial Number 24006; UDI/DI N/A, System ID 540316NM630, Serial Number 24034; UDI/DI N/A, System ID 703523BRIVO, Serial Number 24066; UDI/DI N/A, System ID 920623D615, Serial Number 24028; UDI/DI N/A, System ID 304526B615, Serial Number 24040; UDI/DI N/A, System ID NM24031, Serial Number 24031; UDI/DI N/A, System ID NM24072, Serial Number 24072; UDI/DI N/A, System ID NM24033XXX, Serial Number 24033; UDI/DI N/A, System ID NM24032, Serial Number 24032; UDI/DI N/A, System ID NM24068, Serial Number 24068; UDI/DI N/A, System ID NM3959AR, Serial Number 615V24077; UDI/DI N/A, System ID 030151NU17, Serial Number 24019; UDI/DI N/A, System ID NM24073, Serial Number 24073; UDI/DI N/A, System ID NM24020, Serial Number 24020; UDI/DI N/A, System ID NM24074, Serial Number 24074; UDI/DI N/A, System ID NM24065, Serial Number 24065; UDI/DI N/A, System ID NM24039, Serial Number 24039; UDI/DI N/A, System ID NM24011, Serial Number 24011; UDI/DI N/A, System ID NM24048, Serial Number 24048; UDI/DI N/A, System ID NM24041, Serial Number 24041; UDI/DI N/A, System ID NM24016, Serial Number 24016; UDI/DI N/A, System ID NM615W24079, Serial Number 615W24079; UDI/DI N/A, System ID NM24075, Serial Number 24075; UDI/DI N/A, System ID NM24036, Serial Number 24036; UDI/DI N/A, System ID NM24071, Serial Number 24071; UDI/DI N/A, System ID NM615W24078, Serial Number 615W24078; UDI/DI N/A, System ID NM615W24080, Serial Number 615W24080; UDI/DI N/A, System ID NM24057, Serial Number 24057; UDI/DI N/A, System ID NM24050, Serial Number 24050; UDI/DI N/A, System ID NM24043, Serial Number 24043; UDI/DI N/A, System ID NM24049, Serial Number 24049; UDI/DI N/A, System ID NM24014, Serial Number 24014; UDI/DI N/A, System ID NM24067, Serial Number 24067; UDI/DI N/A, System ID 519767B615, Serial Number 24064; UDI/DI N/A, System ID 905845B615, Serial Number 24063; UDI/DI N/A, System ID 519336BRIVO, Serial Number 24062; UDI/DI N/A, System ID 514934B615AA, Serial Number 24051; UDI/DI N/A, System ID 306766BRIVO, Serial Number 24038; UDI/DI N/A, System ID 306766BRIVO1, Serial Number 24046; UDI/DI N/A, System ID 082426100061, Serial Number 24042; UDI/DI N/A, System ID NM24069, Serial Number 24069; UDI/DI N/A, System ID NM24044, Serial Number 24044; UDI/DI N/A, System ID NM24015, Serial Number 24015; UDI/DI N/A, System ID NM24076, Serial Number 24076; UDI/DI N/A, System ID GE1143NM01, Serial Number 24029; UDI/DI N/A, System ID HC0541NU03, Serial Number 24002; UDI/DI N/A, System ID HC0881NU02, Serial Number 24021; UDI/DI N/A, System ID HLAH01NU05, Serial Number 24047; UDI/DI N/A, System ID HC3366NU02, Serial Number 24010; UDI/DI N/A, System ID HT2106NU07, Serial Number 24055; UDI/DI N/A, System ID 083026241010212, Serial Number 24007; UDI/DI N/A, System ID A268005101, Serial Number 24025; UDI/DI N/A, System ID A5415307, Serial Number 24045; UDI/DI N/A, System ID A5635609, Serial Number 24008; UDI/DI N/A, System ID NM24027, Serial Number 24027; UDI/DI N/A, System ID NM24017, Serial Number 24017; UDI/DI N/A, System ID PL3121NM01, Serial Number 24026; UDI/DI N/A, System ID ZA2446NM01, Serial Number 24005; UDI/DI N/A, System ID ZA1843NM05, Serial Number 24023; UDI/DI N/A, System ID ZA1819NM04, Serial Number 24012; UDI/DI N/A, System ID ZA2101NM01, Serial Number 24054; UDI/DI N/A, System ID DPL83109, Serial Number 24024.
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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.