17
Dec
2003

Varian Brachytherary Virginia Class II

0

Company: Varian Brachytherary Virginia
Date of Enforcement Report: 12/17/03
Class: II

PRODUCT
BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04.

REASON
The manufacturer’s instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to the patient.

CODE
Versions 6.1 and 6.5.

RECALLING FIRM/MANUFACTURER
Varian Brachytherary Virginia, Charlottesville, VA, by Customer Technical Bulletin on May 21, 2003 and by letter on October 31, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
29 sets.

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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