ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic
FDA device recall Z-2812-2015 · posted 2015-09-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
- Action taken
- Siemens sent Notification letters to affected customers. The letter identified the affected product, problem and actions to be taken. The letter advise customers that the software fix was rolled out to address multiple safety issues.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 26
- Distribution
- Worldwide Distribution and US Nationwide
- Date initiated
- 2015-08-05
- Date posted
- 2015-09-24
- Date terminated
- 2016-09-01
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SOLUTION WITH SYS_VB50 UPDATE (K103606) | Siemens Medical Solutions USA, Inc. | 2011-04-15 |
| SYNGO RT THERAPIST CONNECT (K090683) | Siemens Medical Solutions USA, Inc. | 2009-05-08 |
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |
| ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES (K031764) | Siemens Medical Solutions USA, Inc. | 2003-09-05 |
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |