Device product
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.
Z-0826-2016
Product summary
- Event
- Event 73274
- Status
- Terminated
- Classification
- Class II
- Quantity
- 151
- Official record key
device-enforcement:Z-0826-2016
Official wording
Reason: Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
Code information: For model #10091673
Distribution pattern: US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.
Derived failure modes
-
Device software or design
software update that addresses an issue