FDA-Device2014-05-07Class II
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.
Philips Medical Systems (Cleveland) Inc
Hazard
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.
Sold states
Worldwide Distribution -- USA, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Ireland, Italy, Korea, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom.
Affected count
1,043 cameras
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2014Don't want to check this manually?
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