FDA Recall Terminated

syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.

Recall: Z-2762-2011 · Initiated May 10, 2011

Recall

Recall Number
Z-2762-2011
Event Number
58830
Firm
Siemens Medical Solutions, USA, Inc
FEI Number
3003304172
Product Code
LLZ
Status
Terminated
Root Cause
Software design
Initiated
May 10, 2011
Posted
July 8, 2011
Terminated
July 9, 2012
Address
400 Morgan Rd, Ann Arbor, MI, 48108

Description

syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.

Reason

For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.

Action

Siemens Medical Solutions, USA, Inc sent a letter entitled "Customer Safety Advisory Notice" to all direct accounts on May 10, 2011. The letter stated the name and version of the software, problem noted, a work-around to be implemented until a service patch is created to fix the problem, and that the letter should be placed in the software's operator's manual to be seen by all who utilize the software.

Distribution

Nationwide Distribution

Quantity

38