Company:Northwest Medical Physics Equipment, Inc
Date of Enforcement Report:8/15/2007
Class:ll

PRODUCT
Isoloc software Version 6.5, Part Number NT-NW-425-520. Software for image guided radiation therapy, Recall # Z-1145-2007p>
REASON
Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to “Anatomic Landmark” setting.

RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on January 6, 2006. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
132 units

DISTRIBUTION
Nationwide, Korea, Spain, and UK