Date Initiated by Firm |
December 12, 2005 |
Date Posted |
January 25, 2006 |
Recall Status1 |
Terminated 3 on September 04, 2008 |
Recall Number |
Z-0439-06 |
Recall Event ID |
34397 |
510(K)Number |
K040066
|
Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
|
Product |
Arcadis Varic Mobile X-ray System |
Code Information |
model number 8080017 All units |
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 |
patient information can be stored in another patient's file.
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions SP030/05/S. The letter informs customers of the potential problem and provides a suggestion to avoid this issue. |
Quantity in Commerce |
179 units |
Distribution |
The product was 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 = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
|