ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with th
FDA device recall Z-2789-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system
- Action taken
- Siemens Customers Service group began providing Update Instructions and installing the software update on affected machines beginning May 25, 2011. A customer information letter was also provided.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 45 customers with affected configuration in US, 37 customers ROW.
- Distribution
- Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Ar
- Date initiated
- 2011-05-25
- Date posted
- 2011-07-11
- Date terminated
- 2012-03-01
- Location
- Concord, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC (K072486) | Hem Con Medical Technologies, Inc. | 2008-08-06 |
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |