• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Sensis Report Workstation

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Axiom Sensis Report Workstationsee related information
Date Initiated by FirmMay 17, 2004
Date PostedSeptember 14, 2004
Recall Status1 Terminated 3 on April 11, 2005
Recall NumberZ-1446-04
Recall Event ID 29464
510(K)NumberK020440 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
ProductAXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
Code Information Serial Numbers 1002, 1034, 1100-1253, 1300-1504
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactRoland Richter
610-448-1777
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
Other
ActionThe 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 Commerce234 units
DistributionThe product was shipped to 43 medical facilities nationwide and one government account in KY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQK
-
-