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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens

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  Class 3 Device Recall Siemens see related information
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  
Product Classification System, X-Ray, Angiographic - Product Code IZI
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
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
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
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 = IZI and Original Applicant = SIEMENS ELEMA AB
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