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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 Device Recall SKYLight Gamma Camera see related information
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  
Product Classification Emission Computed Tomography System - 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 CA 95134-1702
For Additional Information Contact
408-468-3000
Manufacturer Reason
for Recall		 Detector arm assembly may slide to hardware limit, potentially causing impact.
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
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
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