Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option
FDA device recall Z-2174-2014 · posted 2014-08-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
- Action taken
- An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.
- Root cause
- Use error
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 160
- Distribution
- Nationwide and ROW, including Canada and Mexico.
- Date initiated
- 2014-05-28
- Date posted
- 2014-08-10
- Date terminated
- 2015-07-23
- Location
- Malvern, PA
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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 |
| GENESIS IMRT LINEAR ACCELERATOR (K982502) | Siemens Medical Solutions USA, Inc. | 1998-07-31 |
| MEVATRON 67 (K790688) | Siemens Medical Laboratories, Inc. | 1979-04-23 |