Reported May 11, 2016 · Terminated
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography…
GE Medical Systems, 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 Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
- Lot codes and dates
- Mfg Lot or Serial # System ID
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
- Mfg Lot or Serial # System ID
- Amount recalled
- 26 (US = 4;OUS = 22)
Where it was sold
Why it was recalled
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
This product could cause temporary or reversible health problems — stop using it.
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