LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Me
FDA device recall Z-1059-2015 · posted 2015-02-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission.
- Action taken
- Siemens sent a Customer Advisory Notice Letter TH016/14/S, dated December 19, 2014, to end users that identified the product, problem, and actions to be taken. End users were advised to read the Field Safety Notice and include it with the User's Manual until the hardware update is completed.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 310
- Distribution
- Worldwide Distribution - US Nationwide including Canada and Mexico.
- Date initiated
- 2014-12-19
- Date posted
- 2015-02-05
- Date terminated
- 2017-01-26
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |
| 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 |
| GENESIS IMRT LINEAR ACCELERATOR (K982502) | Siemens Medical Solutions USA, Inc. | 1998-07-31 |