27

Jul

2011

Cl ll Elekta Impac Software Sequencer

0

Company:Impac Medical Systems Inc., .
Date of Enforcement Report 7/27/2011
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. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings. Recall # Z-2662-20.

REASON
There’s a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.

RECALLING FIRM/MANUFACTURER
Impac Medical Systems Inc., Sunnyvale, CA, by letter on March10, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
840 units

DISTRIBUTION
Nationwide and Canada

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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