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U.S. Department of Health and Human Services

Class 2 Device Recall SKYLight Gamma Camera System

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 Class 2 Recall
SKYLight Gamma Camera System
see related information
Date Posted November 19, 2011
Recall Status1 Terminated on December 21, 2012
Recall Number Z-0249-2012
Recall Event ID 60021
Premarket Notification
510(K) Number
K000908 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; 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: 2160-3000A 4535-600-66661
Recalling Firm/
Manufacturer
Philips Medical Systems
3860 N 1st St
San Jose, California 95134-1702
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
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