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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis

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  Class 2 Device Recall Axiom Artis see related information
Date Initiated by Firm June 02, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 21, 2004
Recall Number Z-1108-04
Recall Event ID 29327
510(K)Number K010721  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product SIEMENS AXIOM Artis - AUTOMAP FUNCTION
Code Information Model Numbers:  AXIOM Artis FC 5904433 AXIOM Artis BC 5904649 AXIOM Artis MP 5904466 AXIOM Artis FA 5904441 AXIOM Artis BA 5904656 AXIOM Artis TA 7007755  AXIOM Artis FC: 10050; 10052; 10055; 10064; 10072; 10086; 10094; 10124; 10148; 10151; 10153; 10176; 10177; 10182; 10198; 10217; 10228; 10237; 10240; 10243; 10249; 10251; 10253; 10266; 10284; 10298; 10307; 10326; 10335; 10338; 10348; 10364; 10365;  10367; 10369  AXIOM Artis BC: 14007  AXIOM Artis MP: 20022; 20024; 20032; 20036; 20045; 20048; 20070; 20078; 20082; 20090; 20094; 20107; 20110; 20111; 20155; 20169; 20177; 20190; 20199; 20203; 20205
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.
FDA Determined
Cause 2		 Other
Action The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S.
Quantity in Commerce 127 units
Distribution The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI,
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 MEDICAL CORP.
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