GE Healthcare Optima XR200amx recall
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Why was GE Healthcare Optima XR200amx recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) 5555000-3: UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954WRMCDP2; UDI/DI none, Serial Numbers: 10523MOB01, 201418DIG1, 210297NC200M1, 229276M200, 240566P1, 316858AMX200P1, 401OPTI3, 410368WP1, 443643WP1, 503251XR200, 512SDMCP1, 518243OPT2, 603356OPTIMA, 609267OPT, 609267OPT3, 661949DP1, 661949DP2, 718630OPTIMAX, 760379DP, 801299SB1, 804417OPTIMA, 812237P1, 813745OPT1, 856355OPT, 904244MP1, 904244MP2, 904276DP200, 918477OPT1, 956365OPT1, 956632OPT2, 956632OPT4, XR1037005WK4; 2) 5555000-4: UDI/DI 00840682115278, Serial Numbers: 405717P200, 408259AP8, 518583OPT1, 773792XR200, 7982XR0277, 801230XRA, 904399MP19, 989907DP1; UDI/DI none, Serial Numbers: 1553XR0081, 316962240P1, 361572XR220C, 812265M200, A51043204, FEB520100; 3) A0659MB: UDI/DI 00840682115278, Serial Numbers: XR2262CO.
- Product
- GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 53 units
- Distribution
- Worldwide
- Recall date
- January 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)