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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Sensis Report Workstation

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  Class 2 Device Recall Axiom Sensis Report Workstation see related information
Date Initiated by Firm May 17, 2004
Date Posted September 14, 2004
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-1446-04
Recall Event ID 29464
510(K)Number K020440  
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
Code Information Serial Numbers 1002, 1034, 1100-1253, 1300-1504
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
Manufacturer Reason
for Recall
Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
FDA Determined
Cause 2
Action The recalling firm issued a Customer Safety Advisory to their customers via certified mail on 5/17/04 to inform them of the problem. The advisory provides Update Instructions AX031/04/S to prevent this problem from occurring until the software upgrade is installed to correct the problem.
Quantity in Commerce 234 units
Distribution The product was shipped to 43 medical facilities nationwide and one government account in KY.
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 = DQK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.