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Class 3 Device Recall Siemens |
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Date Initiated by Firm |
November 27, 2002 |
Date Posted |
July 19, 2003 |
Recall Status1 |
Terminated 3 on October 03, 2006 |
Recall Number |
Z-1032-03 |
Recall Event ID |
26574 |
510(K)Number |
K002137
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Product Classification |
System, X-Ray, Angiographic - Product Code IZI
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Product |
Cathcor/LX/Desktop, System, X-Ray, Angiographic |
Code Information |
Serial Numbers:01029, 01033, 01034,01062, 01108, 01110, 01121, 01125, 02048. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Parkway Malvern PA 19355
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For Additional Information Contact |
Roland Richter 610-448-1777
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Manufacturer Reason for Recall |
Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
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FDA Determined Cause 2 |
Other |
Action |
A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002. |
Quantity in Commerce |
9 |
Distribution |
5 Hospitals/Clinics in the US. |
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 = IZI and Original Applicant = SIEMENS ELEMA AB
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