syngo Dynamics Version 9.5
FDA Recall Z-2219-2012 · Posted 2012-08-17
Recalling FirmSiemens Medical Solutions, USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-07-13
Date Terminated2013-07-15
Product Quantity30
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.