Reported Feb 24, 2021 · Terminated
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
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?
- System, X-Ray, Tomography
- ComputedRevolution Apex, Revolution CT with Apex Edition
- Lot codes and dates
- Model Numbers
5590000-20: REV2A1900002CNREV2A2000013CNREV2A2000025CNREV2A2000006CNREV2A2000003CNREV2A2000015CNREV2A1900003CNREV2A2000007CNREV2A2000022CNREV2A2000010CNREV2A2000030CNREV2A2000029CNREV2A2000017CNREV2A2000001CNREV2A2000002CNREV2A2000031CNREV2A2000020CNREV2A2000024CNREV2A2000023CNREV2A2000012CNREV2A2000016CNREV2A1900001CNREV2A2000027CNREV2A2000028CNREV2A2000018CNREV2A1900005CNREV2A2000009CNREV2A2000026CNREV2A2000021CN
- REV2A2000011CN 5590000-21xxx, xxx, xxx* (66 units) *serial number information current as of 01/21/2021
- Model Numbers
- Amount recalled
- 96 units
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
Why it was recalled
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
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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