Philips Medical Systems (Cleveland) Inc 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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).