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.
Z-0214-2020
Product summary
- Event
- Event 84009
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1167 in total
- Official record key
device-enforcement:Z-0214-2020
Official wording
Reason: 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.
Code information: System Code: 882290 and 882291 All systems.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.