FDA-Device2013-04-24Class I

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 received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.

Sold states
Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
Affected count
9,241 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-1098-2013

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