Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS
FDA device recall Z-0980-2015 · posted 2015-01-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur.
- Action taken
- An urgent field safety notice, dated December 2, 2014, was sent to end users advising them to use only Siemens' authorized components for patient treatments as described in the operator's manual.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 320
- Distribution
- Worldwide Distribution - US Nationwide including Canada and Mexico.
- Date initiated
- 2014-12-02
- Date posted
- 2015-01-15
- Date terminated
- 2015-05-12
- 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 |
|---|---|---|
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |
| 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 |