Reported Jan 15, 2025 · Ongoing
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 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 XR220amx, Mobile Digital Radiographic System
- Model Numbers
1) 5555000-122) 5555000-53) 5555000-64) A0659PB5) to be provided
- Lot codes and dates
- 1) 5555000-12: UDI/DI none
- Serial Numbers082407100532; UDI/DI to be provided
- Serial Numbers
0824071605122) 5555000-5: UDI/DI 840682115261
- Serial Numbers
1557XR0205352867XRA478765CDP1509962KV220601358OPTX220620421P3813872OPT3SB2201700099WKUDI/DI none
- Serial Numbers
129 of 129 codes
47931422000028MOB12203694SB3205820DP1208666KDM209334OPT1210703M3240566PX2240964OPT1248465DP3256HHPORT2256HHPORT3256MHPORT1281MSL220281MSL2202305KEN220A306766DMOB2310680PORTDR2314251NAV7325574OPTITBD2330489DIGPORT333OPTI2333OPTI3333OPTI4352596OPT1352LEEDP1352VILDP1386FHODP3401OPTI1405636P2405636P240405752OPT1405752OPT2405752OPT4405DELCITY220407303OPTIMAX220408259AP6417347DPORT1417556P1417556P2417556P3419251DP1419251DP2419383DP1434654OPTIMA435CVXR220480MAYO220A501364OPTI1501364OPTI2509474DR1510437OPT1510727OPT3512SAMCSB513870DP1520TMCOPT2541426XR220559447OPT1559784OPT2561694OPT1561694OPT2
- Serial Numbers
06051MOB06228809XR220228818XR220270798XR220B281KINGOPT3303450SB3303695SB3416323MOB3530888OPT1540981ODP3R540981ODP9615769OPTX220713529MDR220717782OPT47982XR0192802775SB1813681OPT2918307OPT2MHSWOPT2201SA2513MM03SB2201600071WKSB2201700085WKSJRO220P1SJRO220P3UTAHJAZZXR1864COUDI/DI none
- Serial Numbers
110 of 110 codes
0830070015847120850070865085007086608500708700850070913085607025408560702670856070268091026DEMO224510181MOB16140024RX14206598USB7209943OTP1214PH220G228575D220254HHSMOB1256429PORT2270688SB5281338BAPOR1281338CL221281338MDR220281348KWDM2281348KWDM3281KINGOPT1281MWB2202281MWB2203304255OPT220304623OPT220308865GSDP1309779RDIG2314525NAV15314525NAV16318675PW1318675PW2318769RDPT1318769RDPT2330480DP1330480DP2330480DP3330480DP4370OPTI1409938DR1220412232DMX2412372DMX1412647DMX2419291DP4419893DP1423493DP2432685OPT2434799GE220469764XR220H504454XR221504785MD1504873TMD8513732DP1563742NDIG1574267XR220586263DP1586493DP1601798D220
- A0659PBUDI/DI 840682115261
- Serial Numbers702880EROP1; UDI/DI none
- Serial Numbers
206598USB65)
- to be providedUDI/DI none
- Serial Numbers
240826OPT1772SRDP1817HUG220B 860545SB2AUDI/DI to be provided
- Serial Numbers
907852OPT22019SA1075MM04
- Amount recalled
- 281 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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