Reported Jan 17, 2024 · Ongoing
BrightView XCT, Gamma Camera, Product Code 882482
Philips North America
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: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- BrightView XCT, Gamma Camera, Product Code 882482
- Lot codes and dates
- No UDI Serial numbers 7811_12
428 of 428 codes
600037460001996000219600001260001236000065600005160000846000351600025960002126000337600030260001446000193600006860000756000385600002760001246000096000176600026060002986000189600004060001406000146600019760004086000401600010460002896000306600030460000226000015600016311000021600032560000216000056600006060000576000026600005460000336000089600009460000536000082600016560001646000167600019460001716000203600019560002046000220
- No UDI Serial numbers 7811_12
- Amount recalled
- 135 US; 294 OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
This product could cause temporary or reversible health problems — stop using it.
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