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Terminated

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; Registered by Siemens Medical Solutions, Concord, CA. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA Recall Z-1493-2012 · Posted 2012-05-07

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-04-03
Date Terminated2012-07-25

Reason for Recall

Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).

Firm Action

Siemens sent a Safety Advisory Notice with Update to all affected customers. The notice informed the customers of the risk of pressing the Motion Stop button repeatedly during treatment. Work Steps were provided for customers to follow.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution - USA including the states of CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092145160MLC OPTIONSiemens Medical Solutions USA, Inc. · 2009-09-18K072486MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTCHem Con Medical Technologies, Inc. · 2008-08-06

Official Source

View FDA Recall →

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

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