|
Class 2 Device Recall syngo Dynamics version 9.0 |
|
Date Initiated by Firm |
March 24, 2011 |
Date Posted |
May 25, 2011 |
Recall Status1 |
Terminated 3 on July 10, 2012 |
Recall Number |
Z-2293-2011 |
Recall Event ID |
58545 |
510(K)Number |
K102150
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI.
The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images. |
Code Information |
10091602, 10091604 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions, USA, Inc 400 Morgan Rd Ann Arbor MI 48108
|
For Additional Information Contact |
800-422-8766
|
Manufacturer Reason for Recall |
If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm, SIEMENS, sent a "Customer Safety Advisory Notice" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks.
If you have any questions, call +1 (734) 205-2400. |
Quantity in Commerce |
29 devices |
Distribution |
Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA. |
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.
|
|
|
|