SEQUENCER Mosaiq interfaced to Electa SL75-5 Cl ll

Company: Impac Medical Systems Inc., .
Date of Enforcement Report 2/9/2011
Class ll:

PRODUCT
SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control. Recall # Z-1029-2011.

REASON
Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.

RECALLING FIRM/MANUFACTURER
Impac Medical Systems Inc., Sunnyvale, CA, by letter on March 10, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
40 units

DISTRIBUTION
Nationwide, Canada, Germany, and France

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
to receive discount

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.