Cl II CareFusion Alaris PC unit model 8015

Company: CareFusion 303, Inc.
Date of Enforcement Report 6/24/2015
Class lI:


Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Recall Number Z-1811-2015

CareFusion has identified an issue with the Alaris PC unit model 8015 software version 9.17 related to the cancel functionality that be used during atypical infusion programming to cancel user inputted values.

CareFusion 303, Inc., San Diego, CA on 5/13/2015. Voluntary: Firm Initiated recall is ongoing.

63 units



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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