Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA
This recall has been terminated (originally issued November 5, 2009).
- Recall Initiated
- September 10, 2009
- Posted
- November 5, 2009
- Terminated
- December 6, 2010
- Recall Number
- Z-0121-2010
- Quantity
- 97 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.
Lot / Code Info
Product: syngo RT Therapist model/part #8162815 Product: syngo RT Therapist Assist model/part #8162807 Product: syngo RT Therapist Express Basic model/part #8151289 Product: syngo RT Therapist Express Assist model/part #8151289
Root Cause
Software design
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.