Date Initiated by Firm |
August 25, 2008 |
Date Posted |
December 09, 2008 |
Recall Status1 |
Terminated 3 on January 26, 2010 |
Recall Number |
Z-0315-2009 |
Recall Event ID |
49569 |
510(K)Number |
K052202
|
Product Classification |
Angiographic x-ray system - Product Code IZI
|
Product |
AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors.
¿AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
|
Code Information |
Model number 7413078. Serial numbers: 46130, 46150, and 46205. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact |
Michael Van Ryn 610-448-4500
|
Manufacturer Reason for Recall |
System may switch to emergency fluoroscopy mode.
|
FDA Determined Cause 2 |
Software design |
Action |
A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue. |
Quantity in Commerce |
3 units |
Distribution |
Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY. |
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 SOLUTIONS USA, INC.
|