ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assis
FDA device recall Z-1888-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment
- Action taken
- Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009. For further information, contact Siemens Medical Solutions at 1-925-602-8157.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 53 units
- Distribution
- Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.
- Date initiated
- 2009-04-09
- Date posted
- 2009-09-24
- Date terminated
- 2011-04-12
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |