The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard…"

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…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion System
Hazard

Distribution

Distributed nationwide across the United States.

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