Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis dFA

  • 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 Artis dFA see related information
Date Initiated by Firm September 02, 2008
Date Posted November 25, 2008
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-0126-2009
Recall Event ID 49584
510(K)Number K010721  K021021  
Product Classification Angiography X-Ray - Product Code IZI
Product Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373.
Code Information Model number 7555373. Serial numbers: 50080, 50135, 50137, 50138, 50139, 50140, 50141, 50142, 50143, 50144, 50145, 50146, 50147, 501 48, 50149, 50151, 50152, 50153, 50154, 50155, 50156, 50157, 50158, 50159, 50160, 50161, 50163, 50164, 50165, 50166, 50167, 50169, 50170, 50171, 50172, 51708, 51709, 51710, 51711, 51712, and 51713.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Michael Van Ryn
610-448-4500
Manufacturer Reason
for Recall		 Incorrect contour finding: Image may be calibrated to the wrong size catheter.
FDA Determined
Cause 2		 Software design
Action Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
Quantity in Commerce 41 units
Distribution Nationwide.
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.
510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
-
-