Feb

2011

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

About the author

Amy Sellers

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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SEQUENCER Mosaiq interfaced to Electa SL75-5 Cl ll

Amy Sellers

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