Date Initiated by Firm |
January 31, 2007 |
Date Posted |
March 28, 2007 |
Recall Status1 |
Terminated 3 on April 30, 2008 |
Recall Number |
Z-0652-2007 |
Recall Event ID |
37347 |
510(K)Number |
K053133
|
Product Classification |
Medical image report and archive system. - Product Code LLZ
|
Product |
Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system. |
Code Information |
All units. Version 5.0 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions, USA, Inc 400 Morgan Rd Ann Arbor MI 48108
|
For Additional Information Contact |
S. Nina West 734-205-2423
|
Manufacturer Reason for Recall |
The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.
|
FDA Determined Cause 2 |
Other |
Action |
Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided. |
Quantity in Commerce |
71 |
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 = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
|