syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in pictu
FDA device recall Z-0324-2009 · posted 2008-12-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
- Action taken
- The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 130 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-09-12
- Date posted
- 2008-12-03
- Date terminated
- 2009-09-23
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO MULTIMODALITY WORKSTATION (K010938) | Siemens Medical Solutions USA, Inc. | 2001-06-26 |