SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerator
FDA device recall Z-0907-2013 · posted 2013-03-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
- Action taken
- The firm issued "Urgent Medical Device Correction" letters via mail to all its direct consignees, informing them of the affected product issue and providing instructions on the recall. The firm stated that the release of this UI TH005/13/S to distribute the Customer Safety Advisory Notice began on January 17, 2013.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 5 units
- Distribution
- 5 devices, all located outside of the United States in Germany.
- Date initiated
- 2013-01-17
- Date posted
- 2013-03-05
- Date terminated
- 2013-03-05
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTETM SOLUTION WITH SYS VCIO (K121295) | Siemens Medical Solutions USA, Inc. | 2012-06-27 |