Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Sie
FDA device recall Z-1182-2013 · posted 2013-04-26 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software update to fix multiple safety related issues.
- Action taken
- Siemens sent updated instructions of TH004/13/S on April 4, 2013. The SW Update will be delivered by the Siemens Customer Service Group. For questions regarding this recall call 925-293-5442.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 245 active devices
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turk
- Date initiated
- 2013-04-04
- Date posted
- 2013-04-26
- Date terminated
- 2013-08-12
- Location
- Martinez, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SOLUTION WITH SYS_VB50 UPDATE (K103606) | Siemens Medical Solutions USA, Inc. | 2011-04-15 |
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |