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

PRODUCT
ISOLOC 4.2 Software Part Number NT-NW-425-520. Radiation treatment software, Recall # Z-1147-2007p>
REASON
When the ISOLOC (Version 4.2) profile distance unit is set to “centimeter” and the user clicked the “back” button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.

RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on May 31, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
85 units

DISTRIBUTION
Nationwide, Korea, Spain, and UK