24
Jun
2015

Cl II CareFusion Alaris PC unit model 8015

,
0

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

PRODUCT

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

REASON
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.

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

VOLUME OF PRODUCT IN COMMERCE
63 units

DISTRIBUTION
Nationwide

___________________________________

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.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.