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Terminated

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA Recall Z-1182-2013 · Posted 2013-04-26

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-04-04
Date Terminated2013-08-12
Product Quantity245 active devices

Reason for Recall

Software update to fix multiple safety related issues.

Firm Action

Siemens sent updated instructions of TH004/13/S on April 4, 2013. The SW Update will be delivered by the Siemens Customer Service Group. For questions regarding this recall call 925-293-5442.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103606ARTISTE SOLUTION WITH SYS_VB50 UPDATESiemens Medical Solutions USA, Inc. · 2011-04-15K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15K993425PRIMUSSiemens Medical Solutions USA, Inc. · 1999-11-26

Official Source

View FDA Recall →

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

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