01

Aug

2012

ARTISTE or ONCOR Digital Linear Accelerators Cl ll

0

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 8/112
Class ll:

PRODUCT
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Z-2073-2012

REASON
Siemens became aware of a potential safety issue when using the “IMMEDIATE RESUMPTION” feature of the syngo RT Therapist 4.2 software after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments; in a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc , Concord, CA on 6/25/2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18 units

DISTRIBUTION
Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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