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.
This recall has been terminated (originally issued November 1, 2019).
- Recall Initiated
- September 19, 2019
- Posted
- November 1, 2019
- Terminated
- April 5, 2021
- Recall Number
- Z-0217-2020
- Quantity
- 1167 in total
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
System Code: 889471 System Serial Number: 1
Root Cause
Nonconforming Material/Component
Action Taken
On September 19, 2019 the firm distributed Urgent Field Safety Notice (FSN) Medical Device Correction letters by direct communication from Philips Field Service Engineers instructing them to: - Discontinue system use until further notice - Inform those who need to be aware within your organization or any organization where the potentially affected devices have been transferred (If appropriate). - Maintain this notice with your system Instructions for Use (IFU) until the correction is made to the system. ACTIONS PLANNED BY PHILIPS: Philips Healthcare is distributing this FSN to all affected customers/users and will deploy a solution addressing the issue upon completion of the investigation. FURTHER INFORMATION AND SUPPORT: If you need any further information or support concerning this issue, please contact your local Philips representative: For SUPPORT in North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).