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.
