Reported Mar 25, 2015 · Terminated
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The…
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations
- Product UsageThe intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications
- Lot codes and dates
- Mfg Lot or Serial # System ID
944 of 944 codes
0000000010-203203694MIL0000000010-191203852VG10498205933VH10191206288VG10262206598VG10571207795VH10269208529VG1078209334LNVG110340209526milvg10541212562VG1081225763MVG000003100-1829228818MILLVG00008125-18-18248338MLO0210237248828VG10326248937VG1538256235OPNM110171262785vg10392894872VG210802894872VG310316301896VG10177304256VG00000000010-15304487VG10156305612VG10197309662SJVG10539310231VGH110395312864VG1058313299VG00000000010-63334794MILVG1372361575VG000000099-4-04402449SJVG
- Mfg Lot or Serial # System ID
- Amount recalled
- 472 (127 units US, 345 units OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date
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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