FDA-Device2016-07-06Class II
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
CareFusion 303, Inc.
Hazard
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
Sold states
Distributed US (nationwide) and in Canada.
Affected count
69,693 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2064-2016Don't want to check this manually?
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