Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, man
FDA device recall Z-0121-2010 · posted 2009-11-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear Accelerator's Syngo RT Therapist v4.1 Workspace (containing the Siemens brand of Verify and Record application called PRIMEVIEW) and the LANTIS Oncology Information System product.
- Action taken
- The firm issued a TH015/09/S Safety Modification syngo RT Therapist 4.1 Customer Advisory letter, dated September 10. 2009. the letter stated the reason for modification, the affected systems, working time, deadline, reimbursement, and reporting. The firm is preparing a software upgrade for the affected products to correct the problem. The letter was sent via certified mail.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 97 units
- Distribution
- Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.
- Date initiated
- 2009-09-10
- Date posted
- 2009-11-05
- Date terminated
- 2010-12-06
- 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 |