Date Initiated by Firm | September 19, 2019 |
Date Posted | November 01, 2019 |
Recall Status1 |
Terminated 3 on April 05, 2021 |
Recall Number | Z-0213-2020 |
Recall Event ID |
84009 |
510(K)Number | K982911 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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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. |
Code Information |
System Code: 882020 All systems |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Ms. Holly Wright Lee 440-483-7600 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 1167 in total |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPS
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