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Terminated

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 Recall Z-1888-2009 · Posted 2009-09-24

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-04-09
Date Terminated2011-04-12
Product Quantity53 units

Reason for Recall

Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment

Firm 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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072485ARTISTE MV SASiemens Medical Solutions USA, Inc. · 2007-12-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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