Reported Dec 30, 2020 · Terminated
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray…
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 CT with
- Apex Edition CT System - Product Usageintended for head, whole body, cardiac and vascular X-ray Computed Tomography applications
- Lot codes and dates
- Model Number5995000-5
- Serial Number'sREVVX1700078CN (System
- ID713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System
- ID220078CT04)
- and REVVX1800040CN (System IDM2322265/UDI: 01008406821185521118030021REVVX1800040CN)
- Amount recalled
- 3 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
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
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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