Company: Impac Medical Systems Inc.
Date of Enforcement Report 8/20/2008
Class:ll
PRODUCT
SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO. Used to facilitate the delivery of defined radiotherapy treatment plans; Recall # Z-1515-2008
REASON
Software issue may result in change to intended treatment field, Potentially resulting in mistreatment.
RECALLING FIRM/MANUFACTURER
Impac Medical Systems, Inc., Sunnyvale, CA, by letter or telephone on or about February 14, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide and Internationally
