Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Par
FDA device recall Z-1523-2011 · posted 2011-03-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.
- Action taken
- Siemens sent Urgent Medical Device Correction, Safety Advisory Notices to all affected customers on June 29, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their System Owner Manual, Chapter, "Safety Advisory Letter. For questions customers were instructed to contact their Siemens Service Engineer or Application Specialist. For questions regarding this recall call 925-602-8157.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Distribution
- Worldwide Distribution - USA including NC,OH, and the countries of Belgium, Sweden, Germany, Lebanon, Japan, Australia, and Iran.
- Date initiated
- 2010-06-29
- Date posted
- 2011-03-04
- Date terminated
- 2012-03-09
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO RT THERAPIST CONNECT (K090683) | Siemens Medical Solutions USA, Inc. | 2009-05-08 |
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |