Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
FDA device recall Z-1751-2008 · posted 2008-09-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Reason for recall
- Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 18
- Distribution
- Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.
- Date initiated
- 2008-02-08
- Date posted
- 2008-09-29
- Date terminated
- 2009-11-18
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO DYNAMICS, VERSION 6.0 (K070322) | Siemens Medical Solutions USA, Inc. | 2007-02-27 |