Reported Jun 26, 2013 · Terminated
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the…
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 Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of
- the Advantage Workstation and AW ServerAdvantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response
- Lot codes and dates
- Mfg Lot or Serial #SSENTARAPETDST
00000L3A331FA400000L3A3318C40S804VCUPETAWS00S804VCUPETAW00000LE23E908A00000LA707B8CD0000S704783AWS00000L3AB67847000D1L3AB6784700000LA70D61FE0000G29711770100000LFB44C08800000LA70D625700000L2E5D97AC00000LA704C3E700000L021DFE1700000L97BF02A600000L3AA73A5B00000LA70AB28E00000L3AB4D63900000L3AB501ED00000L3AA80D2800000L3AB4D6CC00000L3AB50126SNYPHAWSERVER200000X1233500500000LAEDF9764000S704783HDCT0D1S704783HDCT
201 of 201 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 231 (38 US; 193 OUS)
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.
This product could cause temporary or reversible health problems — stop using it.
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