Company: Impac Medical Systems, Inc.
Date of Enforcement Report 11/24/2010
Class ll:
PRODUCT
Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class 11b. Recall # Z- 0076-2011
REASON
Software issue; matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient..
RECALLING FIRM/MANUFACTURER
Impac Medical Systems, Inc., Sunnyvale, CA, by letter dated September 2010. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
797 units
DISTRIBUTION
Nationwide and Internationally
