Mar

2014

Cl II Elekta Agility. Version 3.0 and 3.1

Company:Elekta, Inc.
Date of Enforcement Report:3/12/2014
Class lI:

PRODUCT

1. Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Recall Number Z-1084-2014

2. Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Recall Number Z-1085-2014

REASON
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta GA. on 11/25/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1. 300
2. 134

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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Cl II Elekta Agility. Version 3.0 and 3.1

Amy Sellers

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