Español
TemporaryFDAOngoing

Can make you unwell for a while. Do not eat it.

Optima XR240amx, Mobile Digital Radiographic System

Check your package for

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
Why
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.
Distributed
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
Company
GE Medical Systems, LLC
Announced
Recall began
Read the official notice

Every recall — food, medication, or medical device — is shown word-for-word from the official FDA or USDA notice, with a link straight to it. Nothing here is summarised, reworded, or filled in. This site is not affiliated with any government agency.

Local Recall