Oct

2009

Cl Il Clinac with Version 7.x Software

Company:Varian Medical Systems Oncology Systems.
Date of Enforcement Report 10/21/2009
Class:ll

PRODUCT
Clinac with Version 7.x Software. Model Numbers: H14, H27 and H29. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Recall # Z-1729-2009

REASON
Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 29, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,933 units

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 Il Clinac with Version 7.x Software

Amy Sellers

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