FDA recall Z-0213-2020

Philips Medical Systems (Cleveland) Inc · Class I · device

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.

Reason for recall

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.

Distribution

Nationwide Distribution.

Key facts

Status
Terminated
Initiation date
2019-09-19
Report date
2019-11-13
Termination date
2021-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0213-2020