Recall Z-1888-2009 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
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.
| Date | Sep 24, 2009 (initiated Apr 9, 2009) |
| Status | Terminated |
| Reason | Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment |
| Root cause | Software design |
| Action | 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. |
| Quantity | 53 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |