Jun

2011

Cl ll Optical Guidance Platform v. 2.6 and 2.6.1

Company: Varian Medical Systems, Inc.
Date of Enforcement Report 6/22/2011
Class ll:

PRODUCT
Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions. Recall # Z-2200-2011.

REASON
A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated March 30, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
598 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 ll Optical Guidance Platform v. 2.6 and 2.6.1

Amy Sellers

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