Reported Jan 16, 2019 · Completed
VariCam
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?
- VariCam
- Lot codes and dates
- Serial Numbers
64 of 64 codes
0000000010-2030000000010-191000003100-182900008125-18-1800000000010-1500000000010-6300008125-16-59000000099-4-0400000000010-3100000000010-8200008125-16-7000008125-18-0900008125-18-1600000000017-641028000000000010-30000003681-180300000000018-24000003100-1840000003101-1502000003100-174400000000017-3600000000016-8600000000017-31106519981999000008125-1630100800000000017-2000000000017-2200000000017-23180400000000030-1400000000030-1500000000010-3700000000010-4400000000010-5500000000030-1600000000018-39170400000ICPO5061216971696000000163-175800000000018-2300000000016-7300000000030-0400000000010-5900000000018-22000003100-1760000003100-17430000000010-134000003100-1719343000003100-17636106100000000010-0400000000030-111649
- Serial Numbers
- Amount recalled
- 64 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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