Recall Z-1751-2008 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions, USA, Inc
Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
| Date | Sep 29, 2008 (initiated Feb 8, 2008) |
| Status | Terminated |
| Reason | Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 18 |
| Distribution | Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070322 | SYNGO DYNAMICS, VERSION 6.0 Siemens Medical Solutions USA, Inc., Feb 27, 2007 |