550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment o
FDA device recall Z-1645-2014 · posted 2014-05-21 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
- Action taken
- Siemens sent an Medical Device Correction, Field Safety Notice of Improvement to End users in March 2014, informing them that a Siemens representative would install a software update. By installation of this software update the issues were solved by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced. Please include this Field Safety Notice in your Digital Linear Accelerator System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority has been informed of this update. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. Further questions please call (610) 219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 120
- Distribution
- USA ( nationwide) Distribution.
- Date initiated
- 2014-04-01
- Date posted
- 2014-05-21
- Date terminated
- 2014-12-11
- 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 |