The Recall Desk
ModerateFDA (Devices)·Z-1835-2013·Announced 2013-08-14

CareFusion Recalls Alaris PC Units Due to Voltage and Communication Issues

CareFusion is recalling Alaris PC units model 8015 because they operate at incorrect voltage and may lose communication between processors.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The source text describes a potential loss of communication and incorrect voltage but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

CareFusion 303, Inc. is recalling Alaris PC units, model 8015, with version 9.12. The recall involves 26,564 total units, including 26,220 units distributed in the United States. The units were distributed nationwide in the US as well as in Australia, Canada, and Europe.

The recall is being conducted because the units are operating at an incorrect voltage. Additionally, the units could potentially experience a loss of communication between the PC Unit main Processor and the Keyboard Processor. The Alaris PC Unit serves as the main user interface unit and power supply for the Alaris System, which is used in professional healthcare environments for infusion and monitoring devices.

Healthcare facilities and consumers should contact CareFusion for instructions on how to address the issue with these specific units.

The recalled product

Product
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use i
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion System
Hazard

Distribution

Distributed nationwide across the United States.

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