Cl ll Sequencer Verify & Record System

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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