ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany. Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer.
This recall has been terminated (originally issued August 10, 2011).
- Recall Initiated
- June 3, 2011
- Posted
- August 10, 2011
- Terminated
- March 30, 2012
- Recall Number
- Z-2977-2011
- Quantity
- 121 devices
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.
Distribution
Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Poland, Saudi Arabia, South Africa, Spain, Sweden, and United Kingdom.
Lot / Code Info
The ARTISTE RT Therapist v4.2 and Oncologist v4.2 is used on the following: syngo RT Oncologist Part # 10652131; Therapist Express Basic, Part # 08151289; syngo RT Therapist, Part # 08162815; syngo RT Therapist Connect / MOSAIQ OSI, part # 08168754.
Root Cause
Software design
Action Taken
Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides preventive measure instructions for customers to use until an update for the system is available.