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Philips Medical Systems (Cleveland) Inc recalls Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit
Recalled November 13, 2019 · FDA recall Z-0214-2020 · Philips Medical Systems (Cleveland)
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. · FDA Class I
Units
1167 in total
Sold at
Nationwide Distribution.
Description
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.
Product
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.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →