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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Sensis

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  Class 2 Device Recall AXIOM Sensis see related information
Date Initiated by Firm July 09, 2004
Date Posted October 22, 2004
Recall Status1 Terminated 3 on September 13, 2005
Recall Number Z-0033-05
Recall Event ID 29826
510(K)Number K020440  
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Code Information Serial numbers: 2001-2011, 2013-2023, 2025-2026, 2028, 2031-2067, 2069-2090, 2092-2132, 2134-2143, 2145-2148, 2150-2158, 2160-2260, 2262, and 2265-2266
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
possible error calculating valve area with the AXIOM Sensis
FDA Determined
Cause 2
Action The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
Quantity in Commerce 143 units
Distribution The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
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.