FDAFDA · Food and drugs·Recall number Z-1098-2013
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.
Published April 24, 2013 · Recall initiated: March 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion Corporation
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
- Lot
- unit model 8015 with software version 9.12
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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