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.
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-0214-2020Don't want to check this manually?
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