Cl ll Elekta Impac

Company: Impac Medical Systems Inc
Date of Enforcement Report 12/1/2010
Class ll:

PRODUCT
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. Recall # Z-0159-2011

REASON
Mistreatment– The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.

RECALLING FIRM/MANUFACTURER
Impac Medical Systems Inc., Sunnyvale, CA, by letter dated February 19, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
19 units

DISTRIBUTION
Nationwide, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy

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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