|
Class 2 Device Recall Axiom Artis |
|
Date Initiated by Firm |
September 09, 2010 |
Date Posted |
October 26, 2010 |
Recall Status1 |
Terminated 3 on September 29, 2012 |
Recall Number |
Z-0144-2011 |
Recall Event ID |
56754 |
510(K)Number |
K021021
|
Product Classification |
System, x-ray, angiographic - Product Code IZI
|
Product |
AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System |
Code Information |
Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755. Mulitple Serial Numbers per Distribution Listing |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
|
For Additional Information Contact |
Customer Service 610-219-6300
|
Manufacturer Reason for Recall |
Sporadic system crash while Perivision is performed.
|
FDA Determined Cause 2 |
Software design |
Action |
Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S.
For questions phone (610) 448-3237. |
Quantity in Commerce |
286 units |
Distribution |
USA - Nationwide Distribution |
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.
|
|
|
|