—#100383

Product

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Serial numbers 10091602 and 10091604

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions, USA, Inc
Address: 400 Morgan Rd, Ann Arbor, Michigan 48108

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-05-10
Posted by FDA: 2011-07-08
Terminated: 2012-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100383. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.