Company: Radionics, Inc
Date of Enforcement Report: 6/23/04
Class: II
PRODUCT
Radionics Head and Neck Localizer (HNL), Version B. Recall # Z-1020-04.
REASON
Software may provide inaccurate coordinates and cause mistreatment.
CODE
Serial Numbers: 032610023, 0326100023, 32690010, 041200023.
RECALLING FIRM/MANUFACTURER
Radionics, Inc., Burlington, MA, by telephone and letters dated May 25, 2004. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
Canada, Germany, and Greece.