Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Med
FDA device recall Z-0927-2009 · posted 2009-01-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc
- Action taken
- An Urgent Medical Device Customer Safety Letter dated October 23, 2008 was issued to consignees via certified mail. The letter identified the issue and preventive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via telephone.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 36 units
- Distribution
- Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada.
- Date initiated
- 2008-10-23
- Date posted
- 2009-01-29
- Date terminated
- 2010-12-09
- Location
- Concord, 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 MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |