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.
Recall
- Recall Number
- Z-0826-2016
- Event Number
- 73274
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 29, 2016
- Posted
- February 19, 2016
- Terminated
- February 16, 2017
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
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.
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.
The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2019 to its customers.The notice described the product, problem and actions to be taken. The customers were instructed to create a new department if immediate resolution is necessary, use workplace for reporting and hand over the customer letter before or during installation of field modification(PSL) distributed with Update Instruction SY013/16P. A software update to resolve reported issues is being released via an Update Instruction SY013/16/P. If you have any questions, contact Regulatory Technical Specialist at 610-448-6478 or email: [email protected].
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.
151