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Terminated

ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.

FDA Recall Z-0168-2016 · Posted 2015-10-27

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-05-05
Date Terminated2017-05-05
Product Quantity158

Reason for Recall

potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option.

Firm Action

Siemens sent Safety Advisory Notices, dated May 5th and 22nd, 2015 to all affected customers to inform them about an update of the Control Console software to correct defects affecting the Control Console with their digital Linear Accelerator. Customers were instructed to ensure everne at their organization is aware of the information in the Advisory Notice. If product was further distributed, please forward Safety Notice to all those affected. For questions regarding this recall call 610-219-6300.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESSiemens Medical Solutions USA, Inc. · 2003-09-05K993425PRIMUSSiemens 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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