FDA-Device2015-06-24Class II
Alaris PC unit model 8015, Infusion pump. software version 9.17 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.
CareFusion 303, Inc.
Hazard
An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
Sold states
US Nationwide Distribution
Affected count
63 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris PC unit model 8015, Infusion pump. software version 9.17 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2015Don't want to check this manually?
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