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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.