Reported Jan 22, 2014 · Terminated
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5,…
GE Healthcare, 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 Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
- Lot codes and dates
- Serial Numbers
1,027 of 1,027 codes
00000002796EN100000002797EN900000002798EN700000002799EN500000002800EN100000002801EN900000102726WK900000102789WK300000102937WK700000130778WK300000UA45526-800001027058WK500001027061WK900001027146WK800001027149WK200001027150WK000001027151WK800001027153WK400001027154WK200001027167WK400001027168WK200001027169WK000001027175WK700001027193WK000001027194WK800001027195WK500001027199WK700001027200WK300001027203WK700001027204WK500001027207WK800001027214WK400001027256WK500001027259WK900001027260WK700001027262WK300001027264WK900001027265WK600001027267WK200001027268WK000001027269WK800001027276WK300001027277WK100001027278WK900001027280WK500001027293WK800001027294WK600001027295WK300001027297WK900001027298WK700001027299WK500001027300WK100001027301WK900001027302WK700001027303WK500001027314WK200001027318WK300001027322WK500001027323WK300001027324WK1
- Serial Numbers
- Amount recalled
- 1027
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- WA
Why it was recalled
There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams w
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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