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Terminated

SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA

FDA Recall Z-0438-2014 · Posted 2013-12-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-10-23
Date Terminated2014-01-22
Product Quantity26 units

Reason for Recall

A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.

Firm Action

Siemens sent an Urgent Medical Device Correction letter dated October 23, 2013 including the release of update instruction TH024/13/S to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.

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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