Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit
FDA device recall Z-0217-2020 · 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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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FORTE GAMMA CAMERA SYSTEM (K033254) | Adac Laboratories | 2003-10-22 |