Reported Sep 4, 2024 · Ongoing
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4)…
GE Healthcare (China) Co., Ltd.
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 Healthcare (China) Co., Ltd. · 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area · Beijing · N/A
Is this the product you have?
11 of 11 products
| # | Product as published |
|---|---|
| 1 | 2259973 |
| 2 | 2259988 |
| 3 | 2266999 |
| 4 | 2373519 |
| 5 | 2379827 |
| 6 | 5729352 |
| 7 | 2259973-1 |
| 8 | 2259973-2 |
| 9 | 2259973-3 |
| 10 | 2259973-4 |
| 11 | Not Available |
- Lot codes and dates
- 1) 2259973:
- UDI/DI noneSystem
- ID Numbers
918485PROT1281410PRO
- UDI/DI 00840682120777
System ID Number 503315PRO2) 2259988:
- UDI/DI 00840682106139System
- ID Numbers
305682PROTEUS305MCPCPRO828262PROT631376ER2716675DPRO1206965XR
- UDI/DI 00840682120777System
- ID Numbers
82 of 82 codes
251435PROT334418PRO334418XRA520MERPRO805652DR2303320TPXR970248PROT203732PROT203876XRA564941792PROTEUS305CGHPROTEUS561495RAD1850837PROTEUS352FRIPRO386LCMCER1813344PROTXR561881ICRAD850469PROT561655XRAFWR1453478289PRO847298AMGPROT630225NWMGE02PXRA630225NWMGEO1D630241PROT317439PROT317338SPORTS317773PROT317204PROT913491PROXR1620421PRO1785543PRO785743PRO598761NVP906483XRA564313745RERPROT1000001522601855PROTEUS662773RAD1662756PRO704323FA704323PROS908237RAD201656PROT575439PROT585227PRO1914964PROT740HVCHPRO740333PROT1740FAYPRO724547XR1864512KCPROT843681PROTEUS843839XR901767PROTXR737202PROTSDNAMCTRAUMA281897XRPRO254751PROLL512SDMCLER
- UDI/DI noneSystem
- ID Numers
2,617 of 2,617 codes
907842PROTX907796ORTHO907796PROT907443PROTEUS907861VER256235ORT1251368ARAD205481PRO205592DCPRO251847RAD205280PRO256737PRO251435R1251275RAD256486XR1256429CR2256782PRO1205387PRO256CCP1256974PR1334732PXRA256332RRM1256356RAD1256386RM4334670RAD205750RAD256487RAD870898PROT479BVXR479709PROT870816PROT501622PROT870972PRO1870972PRO2870245PROTGON4605254870508BJC1870845PROT2501202BNLER870541PROT6479338PROT1501268PROT2870673PROT870226PROT870208RF870208XR1623925XR1480FCCHDXR480MAYOXRDAZGHCHD2XR480603XR1520228PRO520533PRO1928758RAD480984XR1623433XR1623FCGLEXRPHXCAM1XR1RADNETRAD400623322XR
- Amount recalled
- 3572 units
Why it was recalled
The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.
This product could cause temporary or reversible health problems — stop using it.
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