05

Oct

2008

Siemens Radiation therapy system Cl Il

0

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 10/1/2008
Class:ll

PRODUCT
Radiation therapy system – PRIMEVIEW 3i System 2.1 equipped with Coherence
Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged
particle Radiation therapy system, part of the firm’s beam limiting device/accessory.
The product provides data processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation therapy. Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1 Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions,
Recall # Z-2104-2008

REASON
Software – Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter on May 15, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
491 units

DISTRIBUTION
Distribution information pending from firm.

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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