May

2013

Cl ll Siemens Syngo RT Therapist

Company:Siemens Medical
Date of Enforcement Report 5/8/2013
Class ll:

PRODUCT

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Recall Number Z-1182-2013

REASON
Software update to fix multiple safety related issues.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Martinez, CA on 4/4/2013 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
245 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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Cl ll Siemens Syngo RT Therapist

Amy Sellers

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