|
Class 2 Device Recall Siemens syngo.plaza |
|
Date Initiated by Firm |
August 08, 2011 |
Date Posted |
November 13, 2013 |
Recall Status1 |
Terminated 3 on November 06, 2014 |
Recall Number |
Z-0271-2014 |
Recall Event ID |
65792 |
510(K)Number |
K093612
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
Siemens syngo.plaza image processing system
image processing radiological system |
Code Information |
Model Number 10592457 with serial numbers 100263, 100177, 100138, 100174, 100005, 100006, 100007, 100008, 100009, 100010, 100219, 100201, 100198, 100181, 100249, 100301, 100302, 100157, 100146 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
|
For Additional Information Contact |
Siemens Customer Service 610-219-6300
|
Manufacturer Reason for Recall |
The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.
|
FDA Determined Cause 2 |
Software design |
Action |
Siemens sent a Customer Safety Advisory Notice dated August 3, 2011, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to forward the Customer Safety Advisory Notice to their customers. If necessary, customers should have the letter translated technically into the local language and copy it themselves. A letter was sent to direct accounts to inform them of the issu and provide instructions to avoid encountering the problem.
For questions regarding this recall call 610-219-6300. |
Quantity in Commerce |
19 |
Distribution |
Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA. |
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 AG, MEDICAL SOLUTIONS
|
|
|
|