Reported Jan 17, 2024 · Ongoing
BrightView, Gamma Camera System, Product Code 882480.
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, Gamma Camera System, Product Code 882480.
- Lot codes and dates
- No UDI Serial numbers7135_11
4000002400026240006814000218400041340003124000389400067840004844000288400039340003934000494400035440006994000515400067940004794000689400008240003734000471400054540003314000038400000240000604000161400016440003604000175400024440001864000242400023540002554000247400032040003474000367400040240004304000473400059140005374000505400052940005244000562400058240006064000583400058440006624000674400069640002824000449
4000197_1107 of 107 codes
40004104000651400065240006654000688400035040000444000061400008140000654000002.754000180400022440003214000229400028040003784000559400055240002984000009400019040001844000305400030340003244000411400051640005544000566400057640006144000612400062740006694000033400007040000914000123400010240000084000202400016640002764000287400036440004554000498400049740000124000213400019740003534000335400041840005104000436400045440004694000500
520 of 520 codes
40004874000466400038140005364000549400055740005504000031400056040005674000483400062040006074000601400068340003434000540400054740003164000317400033840004084000342400042140005114000495400060440006644000682458008400004140000304000167400020340004074000341400064740001254000279400021640002694000254400020840003454000415400067240002864000294400039540003904340005400019940002814000211400009640003484000613400065540004194000464
- No UDI Serial numbers
- Amount recalled
- 359 US; 328 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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