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U.S. Department of Health and Human Services

Class 2 Device Recall Precedence

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 Class 2 Device Recall Precedencesee related information
Date Initiated by FirmDecember 28, 2010
Date PostedMarch 04, 2011
Recall Status1 Terminated 3 on April 02, 2012
Recall NumberZ-1550-2011
Recall Event ID 57589
510(K)NumberK041218 
Product Classification Computed Tomography X-Ray System - Product Code JAK
ProductPrecedence 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 CA 95134-1702
For Additional Information ContactElizabeth 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
ActionUrgent - 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 Commerce540 total units, all varieties
DistributionWorldwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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