Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens
FDA device recall Z-1038-2008 · posted 2008-04-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.
- Action taken
- Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 47 Units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-12-21
- Date posted
- 2008-04-29
- Date terminated
- 2008-09-30
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEONARDO (K040970) | Siemens Medical Systems, Inc. | 2004-07-08 |