FDA-Device2013-04-24Class II
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Carefusion Corporation
Hazard
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
Sold states
Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
Affected count
4,090 total units
Manufactured in
3750 Torrey View Ct, N/A, San Diego, CA, United States
Products
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1112-2013Don't want to check this manually?
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