Reported Jun 10, 2020 · Ongoing
System, Tomography Computed Emmission
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, Tomography Computed Emmission
- Lot codes and dates
- Model for Ventry
ASM001605H3000YTH3000YWH3000YY
- H3000ZW Serial Numbers
352 of 352 codes
110751143011137111541113811512113221109311301112861129411021110781112511235113871133711288113961114711039114271132811471112511142411448114211145011203114681136319016110691112711284111241122911057111431151511190110011102711297113061106111151111611144111248110671124711435110771151311497112061121111347
- Model for Ventry
- Amount recalled
- 526 total 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 identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
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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