Skip to content
Recall Observatory FDA recall evidence

Device product

Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.

Z-0534-2014

December 05, 2013

Class I

Product summary

Firm
CareFusion 303, Inc.
Event
Event 66865
Status
Terminated
Classification
Class I
Quantity
4824 total units (4242 units in US)
Official record key
device-enforcement:Z-0534-2014

Official wording

Reason: CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

Code information: not available

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.