FDA Enforcement
Class I
Terminated
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.
Recall: Z-0217-2020
·
Reported November 13, 2019
Enforcement
- Recall Number
- Z-0217-2020
- Event ID
- 84009
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- November 13, 2019
- Initiation Date
- September 19, 2019
- Classification Date
- November 1, 2019
- Termination Date
- April 5, 2021
- Address
- 595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States
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
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 Info
System Code: 889471 System Serial Number: 1
Distribution
Nationwide Distribution.
Quantity
1167 in total