Z-1098-2013 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- March 6, 2013
- Termination Date
- September 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,241 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
Code Information
unit model 8015 with software version 9.12