FDA-Device2019-11-13Class I
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Philips Medical Systems (Cleveland) Inc
Hazard
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Sold states
Nationwide Distribution.
Affected count
1167 in total
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0216-2020Don't want to check this manually?
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