Aug

2016

Cl II Elekta MOSAIQ Oncology Information System

Company: Elekta, Inc.
Date of Enforcement Report 8/3/2016
Class lI:

PRODUCT

MOSAIQ Oncology Information System
Recall Number Z-2293-2016

REASON
It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

RECALLING FIRM/MANUFACTURER
Elekta, Inc., Atlanta, GA on 7/15/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
383

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 MOSAIQ Oncology Information System

Amy Sellers

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