Z-2728-2026 Class II Ongoing
FDA device recall Z-2728-2026 was initiated by GE Medical Systems, LLC on June 5, 2026 and is designated Class II. Reason for recall: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confir… The recall status is ongoing. Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- June 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
Optima XR240amx, Mobile Digital Radiographic System
Reason for Recall
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Distribution Pattern
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
Code Information
UDI-DI: 00840682122351 and 00840682123686; System IDs: 252847PP249, 281MSL2402, 291OPTI1, 312CCHSUPER7, 318487OPTIMA1, 360744OPT2402, 501686OPTI1, 504826XR241, 519941XR240A, 540776ODP3, 541472M4, 602344240C, 706291BEE9, 713799XR240, 770836BEE2, 813872OPT11, 813872OPT9, 843724OPT1, 843847OPT240, 870239OPT2, 905522AMX240, 973625DIG4, DF2402001002WK, SA1013MM13