Reported May 7, 2014 · Terminated
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System,…
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 Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
- Lot codes and dates
- ADAC
- Vertex Plus & ADAC Solus System Code
768 of 768 codes
88297Serial #'s: 1110061008102710921097203520382047305930603064400740786052626180021025210630110908524751351951352094038492053459408136950308495060169511123951200995120189601012960101596010169601024960103696021619602254960333696040169604021960502496050269605037960621196070159607024960803196080469608049960805296090639609081961005896110359611077961108296120729702095
- ADAC Vertex V60 System Code
882030Serial #'s: 105889601004V0005062V03080235V03080236& V2070177
- ADAC Vertex Classic System Code
128 of 128 codes
890122Serial #'s: 6410350033345005930800793090209310032940105994010619403076940410694071229410002941100694110169501210950206795020709503003950307995031099504019950409995050219505124950614095061789508171950818495081939509206951022295102269601146960224996080429609084990100499011350407V0682V0795V0822VP2205405V93-10660-1292940812894110079502086950816995091989509199B0106154B02120033M@10229AMTM@207JDM@4324VM@4404V
- Amount recalled
- 1,043 cameras
Why it was recalled
Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.
This product could cause temporary or reversible health problems — stop using it.
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