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U.S. Department of Health and Human Services

Class 2 Device Recall Gamma Camera System, Tomography, Computed, Emission

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  Class 2 Device Recall Gamma Camera System, Tomography, Computed, Emission see related information
Date Initiated by Firm January 23, 2003
Date Posted February 21, 2003
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-0563-03
Recall Event ID 25518
510(K)Number k882312  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
Code Information All serial numbers of Models N210060 and N210335.
Recalling Firm/
Manufacturer		 Philips Medical Systems Inc
595 Miner Rd
Cleveland OH 44143
Manufacturer Reason
for Recall		 The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
FDA Determined
Cause 2		 Other
Action The firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.
Quantity in Commerce 311 units
Distribution The sytems were shipped to end-users located nationwide and worldwide.
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 = OHIO IMAGING, INC.
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