22

Jun

2011

Cl ll ARTISTE / RT Therapist v4.1 system

0

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 6/22/2011
Class ll:

PRODUCT
ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ARTIST Systems include: Therapist Express Basic Part number 08515289; Therapist Express Assist Part number 08515297; syngo RT Therapist Assist Part number 08162807; syngo RT Therapist Part number 08162815; and sysno RT Therapist connect/MPSAOQ OIS Part number 08168754. Recall # Z-2190-2011

REASON
When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 24, 2011.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
228 active devices

DISTRIBUTION
Nationwide and Internationally

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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