syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system inten

FDA device recall Z-2762-2011 · posted 2011-07-08 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions, USA, Inc

Reason for recall

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 taken

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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

38

Distribution

Nationwide Distribution

Date initiated

2011-05-10

Date posted

2011-07-08

Date terminated

2012-07-09

Location

Ann Arbor, MI