ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Medical charged-particle radiation therapy system.
This recall has been terminated (originally issued September 24, 2009).
- Recall Initiated
- April 9, 2009
- Posted
- September 24, 2009
- Terminated
- April 12, 2011
- Recall Number
- Z-1888-2009
- Quantity
- 53 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment
Distribution
Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.
Lot / Code Info
All Product with Part Number 8139789 (RT Therapists are part of the system).
Root Cause
Software design
Action Taken
Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009. For further information, contact Siemens Medical Solutions at 1-925-602-8157.
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