Reported Jul 22, 2026 · Ongoing
Optima XR240amx, Mobile Digital Radiographic System
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Optima XR240amx, Mobile Digital Radiographic System
- Lot codes and dates
- UDI-DI00840682122351 and 00840682123686
- System IDs
252847PP249281MSL2402291OPTI1312CCHSUPER7318487OPTIMA1360744OPT2402501686OPTI1504826XR241519941XR240A540776ODP3541472M4602344240C706291BEE9713799XR240770836BEE2813872OPT11813872OPT9843724OPT1843847OPT240870239OPT2905522AMX240973625DIG4DF2402001002WKSA1013MM13
- Amount recalled
- 24 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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