FDA Medical Device Recalls (openFDA)
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 number
- Z-0217-2020
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Status
- Terminated
- Initiated
- 2019-09-19
- Posted
- 2019-11-01
- Terminated
- 2021-04-05
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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).
- Quantity
- 1167 in total
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- System Code: 889471 System Serial Number: 1
- 510(k) numbers
- ["K033254"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28