Reported Jan 15, 2025 · Ongoing
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3)…
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?
- GE Healthcare Optima XR240amx, Mobile Digital Radiographic System
- Model Numbers
1) 5555000-272) 5555000-313) 5555000-334) 5555000-415) 5555000-476) A0700DL7) A1700DA8) To be provided
- Lot codes and dates
- 1) 5555000-27: UDI/DI 840682122351
- Serial Numbers
228867XR240252847PP241281274OPT1281338CL240281VHVXR240305682DIG1305682DIG3305KEN240B401OPTI2405949OPT1408559XRDR7413447OPT1419251OPT419690DP1504842XR242602344240A602344MARY240713440DP2713440DP3720854DF1732222DP3763520XR10763520XRA6806725OPT865305DP1941276XRA970495OPTI1973926OPT1BOLDWPACPORT02GLEDWPACPORT02HMHWT240P5LIHOPTIMA240BOCHSNERWB240SAMC240A2) 5555000-31: UDI/DI 840682122351
- Serial Numbers
00158MOB17DF2401800221WKU416249MOB2403) 5555000-33: UDI/DI 840682122351
- Serial Numbers
082407100689228867XR240C4) 5555000-41: UDI/DI 840682122351
- Serial Numbers
00130MOB165973XR0225DEF11034RS4025RX05SA1058MM505) 5555000-47: UDI/DI 840682122351
- Serial Numbers
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
- A0700DLUDI/DI 840682122351
- Serial Numbers
0824072502237)
- A1700DAUDI/DI 840682122351
- Serial Numbers
210METM2256543OPT337261OPT360744OPT2402425899OPT425SNORIDGE509946AMX1573814DP8574231OPT2702852OPT850864FWDH2401HMHXR240P1OMCTOPT18)
- To be providedUDI/DI To be provided
- Serial Numbers
256543OPT1405657FP1417513952OPT2RU1018RX04
- Amount recalled
- 120 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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