Company:Northwest Medical Physics Equipment, Inc
Date of Enforcement Report:8/15/2007
Class:ll
PRODUCT
ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment, Recall # Z-1146-2007p>
REASON
This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 7, 2006. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
141 units
DISTRIBUTION
Nationwide, Korea, Spain, and UK