• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dynamics Version 9.5

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
syngo Dynamics Version 9.5
see related information
Date Posted August 17, 2012
Recall Status1 Terminated on July 15, 2013
Recall Number Z-2219-2012
Recall Event ID 62581
Premarket Notification
510(K) Number
K102150 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Dynamics Version 9.5
Code Information 10091862 and 10091863
Recalling Firm/
Manufacturer
Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor, Michigan 48108
For Additional Information Contact Yuri Ikeda
800-422-8766
Manufacturer Reason
for Recall
If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
Action On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY064/121S.
Quantity in Commerce 30
Distribution Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
Total Product Life Cycle TPLC Device Report

 
1 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.
-
-