Reported Jan 17, 2024 · Ongoing
BrightView X, Gamma Camera, Product Code 882478
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 X, Gamma Camera, Product Code 882478
- Lot codes and dates
- No UDI Serial numbers
118 of 118 codes
11000072110001161100000711000010113400011100002711000032400057011000041110000921100011311340003110000441100000611000033110000251100010511000016110000031100001811000065110000471100006611000101110001071100009011000029110000561100002611000046110000511100007811000114110000671100005011000084110000681100005211000057110000551100007011000088110000231100006111000060110000951100009411000102110000541134000411000091110000831100009811000063110000131100001511000062110000351100008111000009
- No UDI Serial numbers
- Amount recalled
- 59 US; 59 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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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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