16
Dec
2011

Cl ll Elekta Synergy XVI R.4.5 & R4.6 Product Use

0

Company:Elekta, Inc.
Date of Enforcement Report 12/15/11
Class ll:

PRODUCT
Elekta Synergy XVI R.4.5 and R4.6 Product Usage: To be used as part of radiation therapy treatment process. Recall # Z-0320-2012

REASON
The software did not operate as expected.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 14, 2011.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
77 units

DISTRIBUTION
Nationwide and PR

About the author

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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