Philips Medical Systems (Cleveland) Inc recalls Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posi…

Recall date

September 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0214-2020

FDA classification

Class I

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Nationwide Distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.