Reported Oct 23, 2013 · Terminated
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission…
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?
- GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
- Lot codes and dates
- MfgLotorSerial#Shipped Shipped Shipped 00000429572CN1 00000428755CN3 00000428755CN3 00000428868CN4 00000293949HM4 00000428536CN7 00000429820CN4
00000428413CN900000429077CN100000429247CN000000430152CN900000430656CN900000430999CN300000431369CN800000429701CN600000430064CN600000431187CN400000429354CN400000431447CN200000293950HM200000429821CN200000429946CN700000430001CN800000293950HM200000430632CN0
- MfgLotorSerial#
- Amount recalled
- 28 (4 US & 24OUS)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
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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