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Class 2 Device Recall Gamma Camera System, Tomography, Computed, Emission |
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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
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Product Classification |
System, Tomography, Computed, Emission - Product Code KPS
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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
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Manufacturer Reason for Recall |
The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
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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
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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 = OHIO IMAGING, INC.
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