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U.S. Department of Health and Human Services

Class 2 Device Recall Precedence System

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  Class 2 Device Recall Precedence System see related information
Date Initiated by Firm September 27, 2011
Date Posted November 19, 2011
Recall Status1 Terminated 3 on December 21, 2012
Recall Number Z-0255-2012
Recall Event ID 60021
510(K)Number K041218  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Precedence System;

Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.

The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
Code Information Model numbers: 2169-3001A  4535-602-50861. 
Recalling Firm/
Philips Medical Systems
3860 N 1st St
San Jose CA 95134-1702
Manufacturer Reason
for Recall
A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
FDA Determined
Cause 2
Device Design
Action Philips Medical Systems sent a "Customer Information" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice.
Quantity in Commerce 658 - all units in recall
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES