Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Intended use: medical charged-particle radiation therapy system
This recall has been terminated (originally issued February 8, 2011).
- Recall Initiated
- July 30, 2009
- Posted
- February 8, 2011
- Terminated
- April 12, 2011
- Recall Number
- Z-1064-2011
- Quantity
- 151 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.
Distribution
Worldwide distribution: USA and countries including: Germany, France, Poland, Norway, Australia, Malaysia, Spain, New Zealand, the UK, India, Republic of Korea, Canada, Ireland, Italy, Egypt, Belgium, Philippines, Saudi Arabia, Netherlands, Hungary, Norway and South Africa.
Lot / Code Info
Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Basic part number 8151289. Optional parts: Syngo RT Therapist assist part number 8162807, Therapist Express Assist part number 8151297.
Root Cause
Software design
Action Taken
The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation. If you have any questions, call 1-925-602-8157.