Recalls / —
—#83817
Product
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.
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K072485
- Affected lot / code info
- All Product with Part Number 8139789 (RT Therapists are part of the system).
Why it was recalled
Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 4040 Nelson Ave, Concord, California 94520-1200
Distribution
- Distribution pattern
- Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.
Timeline
- Recall initiated
- 2009-04-09
- Posted by FDA
- 2009-09-24
- Terminated
- 2011-04-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #83817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.