Z-0216-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- September 19, 2019
- Termination Date
- April 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1167 in total
Product Description
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 Pattern
Nationwide Distribution.
Code Information
System Code: 889456 System Serial Number: 24