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Terminated

ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.

FDA Recall Z-0459-2012 · Posted 2012-01-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-11-09
Date Terminated2013-04-15
Product Quantity13 active devices

Reason for Recall

Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.

Firm Action

Siemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103505ALTUM ANTERIOR CERVICAL PLATESpinecraft, LLC · 2011-03-15K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15

Official Source

View FDA Recall →

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

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