—#177005

Product

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033254
Affected lot / code info: System Code: 882320 and 882321 All systems.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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).

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2019-09-19
Posted by FDA: 2019-11-01
Terminated: 2021-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.