Reported Nov 4, 2020 · Terminated
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head,…
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?
- Revolution Apex, Revolution CT with Apex Edition
- Model 5995000-5 - Product UsageThe system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications
- Lot codes and dates
- Model 5995000-5
- Lot/Serial Numbers as below4 included units with lot/serials not available
REVVX1800093CNREVVX1700044CNREVVX1900040CNREVVX2000001CNREV2A1900002CNREV2A2000014CNREVVX2000031CNREV2A2000013CNREVVX1600023CNREVVX1800015CNREVVX1900092CNREV2A2000006CNREVVX1900003CNREV2A2000003CNREV2A2000015CNREV2A1900003CNREVVX1800061CNREV2A2000007CNREVVX1700078CNREVVX1900071CNREVVX1900006CNREVVX1900003CNREVVX1800124CNREVVX1800030CN441066CN800000436942CN7REV2A2000010CN00000442968CN4REVVX1900049CN00000439505CN9REVVX1700064CN00000440315CN0REV2A2000017CNDUMFMI25490001REV2A2000001CN00000442412CN3REV2A2000002CNREVVX1700054CNREVVX1800100CNREV2A2000012CNREVVX1800040CNREVVX1600046CNREV2A2000016CNREGGL2000003YCREVVX1900013CNREVVX1600030CNREV2A1900001CNREVVX1700117CNREVVX1800083CNREVVX1700106CN00000440441CN4REV2A2000018CNREV2A1900005CNREV2A2000009CN00000438438CN4REVVX1900102CNREV2A2000011CNREV2A2000004CNDUMFMI25490005
- Amount recalled
- 64 devices
Where it was sold
Why it was recalled
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
This product could cause temporary or reversible health problems — stop using it.
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