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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/
Siemens Medical Solutions USA, Inc
51 Valley Stream Parkway
Malvern PA 19355
For Additional Information Contact Roland Richter
Manufacturer Reason
for Recall
Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
FDA Determined
Cause 2
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