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Class 2 Device Recall SKYLight Gamma Camera |
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Date Initiated by Firm |
October 15, 2010 |
Date Posted |
November 17, 2010 |
Recall Status1 |
Terminated 3 on March 21, 2012 |
Recall Number |
Z-0398-2011 |
Recall Event ID |
57029 |
510(K)Number |
K000908
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Product Classification |
Emission Computed Tomography System - Product Code KPS
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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 CA 95134-1702
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For Additional Information Contact |
408-468-3000
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Manufacturer Reason for Recall |
Detector arm assembly may slide to hardware limit, potentially causing impact.
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FDA Determined Cause 2 |
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
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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 and Original Applicant = ADAC LABORATORIES
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