Z-1098-2013 Class I Terminated
FDA device recall Z-1098-2013 was initiated by Carefusion Corporation on March 6, 2013 and is designated Class I. 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… The recall status is terminated (terminated September 2, 2014). Affected quantity: 9,241 units.
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