Device product
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.
Z-1098-2013
Product summary
- Event
- Event 64728
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9,241 units
- Official record key
device-enforcement:Z-1098-2013
Official wording
Reason: 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.
Code information: unit model 8015 with software version 9.12
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
Derived failure modes
-
Device software or design
error on the Alaris PC unit model 8015 with software