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U.S. Department of Health and Human Services

Class 2 Device Recall Precedence

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 Class 2 Recall
Precedence
see related information
Date Posted March 04, 2011
Recall Status1 Terminated on April 02, 2012
Recall Number Z-1550-2011
Recall Event ID 57589
Premarket Notification
510(K) Number
K041218 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 Philips Medical Systems An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.
Code Information Catalog number 882351; Model numbers (3/8): 4535-602-53551,2169-3002A; Serial numbers: 3000039 KP06090002 KP05070002 3000034 3000038 3000027 Model numbers (5/8); 4535-602-53561,2169-3003A. Serial number: KP06080001
Recalling Firm/
Manufacturer
Philips Medical Systems
3860 N 1st St
San Jose, California 95134-1702
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Elizabeth McLain
608-288-6948
Manufacturer Reason
for Recall
Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.
Quantity in Commerce 540 total units, all varieties
Distribution Worldwide Distribution
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 = JAK and Original Applicant = ADAC LABORATORIES
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