Apr

2014

Elekta Integrity 1.1 Cl II

Company:Elekta, Inc.
Date of Enforcement Report:4/92/2014
Class lI:

PRODUCT

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Recall Number Z-1322-2014

REASON
The problem is that the “static tolerances” from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta GA. on 3/28/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
498

DISTRIBUTION
Nationwide and Internationally

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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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Elekta Integrity 1.1 Cl II

Amy Sellers

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