FDA-Device2017-03-29Class II
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
CareFusion 303, Inc.
Hazard
Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
Sold states
Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Affected count
613,800 total units (575,221 units in US)
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2017Don't want to check this manually?
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