Reported May 20, 2015 · Terminated
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems,…
Philips Medical Systems (Cleveland) Inc.
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 Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
- Lot codes and dates
123 of 123 codes
Vertex ClassicModel #: 890122Serial #s: 9404100960123896090840407V0682V0795V0822VP2103205005405V6493080079309020931003293-10660-12929401059940106194030769403083940410694071229409148941000294110069411007941101695010499501210950206795020869503003950307995031099504019950502195051249506140950816995081719508184950819395091989509206951022295102269601146960224996080429901004B0106154B02120033M@10229AMTM@207JDM@4404VM@4431VM@4432VM@4480V
- VERTEX PLUS/SOLUS/CARDIO
726 of 726 codes
Model #: 88297Serial #s: 96030159605036961007696100779703171970619297101039711277980230498031099807121980812298090569809124980941598094249912461_0002032~96080520007001M0008009B0011002B0102019V0103020V01069VM01070VM0111001V01295VM01296K01864VM03026VM0939VM100098-01N100610081025210271037106301092109711130234-01NVERTEX203520382047305930603064400740785934V605262617373VM7376VM7386VM7560VM7561VM
- Amount recalled
- 918 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
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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