Date Initiated by Firm |
April 19, 2003 |
Date Posted |
July 08, 2003 |
Recall Status1 |
Terminated 3 on August 25, 2004 |
Recall Number |
Z-0984-03 |
Recall Event ID |
26596 |
510(K)Number |
K013826
|
Product Classification |
System, X-Ray, Stationary - Product Code KPR
|
Product |
Axiom Aristos X-Ray System. |
Code Information |
part numbers 5895003 and 7414803. serial numbers 01001, 01170, 01219, 01221, and 01030. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Parkway Malvern PA 19355
|
For Additional Information Contact |
Roland Richter 610-448-1777
|
Manufacturer Reason for Recall |
software malfunction. May indicate that the image is flipped when it is not.
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived. |
Quantity in Commerce |
5 units |
Distribution |
The units were shipped to medical facilities 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 = KPR and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
|