Reported Jan 15, 2025 · Ongoing
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
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 XR200amx, Mobile Digital Radiographic System
- Model Numbers
1) 5555000-32) 5555000-4: 3) A0659MB
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00840682115278UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954WRMCDP2 2 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 3 008406821152785555000-4: UDI/DI 00840682115278, Serial Numbers: 405717P200, 408259AP8, 518583OPT1, 773792XR200, 7982XR0277, 801230XRA, 904399MP19, 989907DP1 4 UDI/DI none, Serial Numbers: 1553XR0081, 316962240P1, 361572XR220C, 812265M200, A51043204, FEB520100 5 00840682115278A0659MB: UDI/DI 00840682115278, Serial Numbers: XR2262CO. - Amount recalled
- 53 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.
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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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