Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit

FDA device recall Z-0213-2020 · posted 2019-11-01 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

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).

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KPS

Quantity affected

1167 in total

Distribution

Nationwide Distribution.

Date initiated

2019-09-19

Date posted

2019-11-01

Date terminated

2021-04-05

Location

Cleveland, OH

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