01
Sep
2011

Eclipse Treatment Planning System Cl ll

0

Company: Varian Medical Systems, Inc.
Date of Enforcement Report 8/31/11
Class ll:

PRODUCT
Eclipse Treatment Planning System; Radiotherapy treatment for patients with malignant and benign diseases. Model No. H48. Recall # Z-2788-2011

REASON
A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 20, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
10,356 units

DISTRIBUTION
Nationwide and Internationally

About the author

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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