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U.S. Department of Health and Human Services

Class 2 Device Recall SKYLight Gamma Camera

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 Class 2 Recall
SKYLight Gamma Camera
see related information
Date Posted November 17, 2010
Recall Status1 Terminated on March 21, 2012
Recall Number Z-0398-2011
Recall Event ID 57029
Premarket Notification
510(K) Number
K000908 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
Code Information 3/8" SPECT, Model number 4535 600 66661, and 5/8 SPECT, Model number 4535 602 20381, all units manufactured between July 2001 to August 2003.
Recalling Firm/
Manufacturer
Philips Medical Systems
3860 N 1st St
San Jose, California 95134-1702
Manufacturer Reason
for Recall
Detector arm assembly may slide to hardware limit, potentially causing impact.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information concerning this issue, they are to contact their local Philips representative.
Quantity in Commerce 24 units
Distribution Worldwide Distribution -- USA and the Netherlands.
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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