Recalls / —

—#68308

Product

Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K070322

Affected lot / code info

All units with version 6.0 software.

Why it was recalled

Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued a customer safety advisory to users on 2/8/08 advising them of the problem and instructing them to complete and verify that the report is locked before opening and reporting on a second patient, and that a software patch will be available Spring 2008.

Recalling firm

Firm

Siemens Medical Solutions, USA, Inc

Address

400 Morgan Rd, Ann Arbor, Michigan 48108

Distribution

Distribution pattern

Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.

Timeline

Recall initiated

2008-02-08

Posted by FDA

2008-09-29

Terminated

2009-11-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #68308. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.