Device evidence

device-recall:cfres:177005

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 recall number

Z-0215-2020

Evidence summary

Product code: KPS
Recall status: Terminated
Event initiated: September 19, 2019
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0215-2020