CareFusion Alaris PC Unit Model 8015 Recalled for Power-Up Error
CareFusion 303, Inc. is recalling 23,397 Alaris PC units, Model 8015, because a super capacitor failure may cause a system error code at power-up.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may fail to power up correctly, posing a risk of harm without reported injuries.
Plain-English summary
CareFusion 303, Inc. is recalling 23,397 units of the Alaris PC unit, Model 8015. This device serves as the central programming, monitoring, and power supply component for the Alaris System.
The recall is due to a potential failure of the super capacitor (C245) on the Alaris PC unit logic boards. This failure may cause the unit to display system error code 133.6080 during power-up.
The affected units were distributed nationwide in the United States, as well as in Australia, Great Britain, and Canada. Specific serial numbers are listed in the official recall documentation.
The recalled product
- Product
- Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 23,397
Distribution
Distributed nationwide across the United States.
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Similar recalls
- SevereCareFusion Alaris PC Unit Model 8015 Recalled for Power Supply Board Error
FDA (Devices) · 2012-08-01
- SevereCareFusion Recalls Alaris PC Units Due to Voltage and Communication Issues
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- HighCareFusion Alaris System PC Unit Recall for Battery Alarm Failure
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- SevereCarefusion Recalls Alaris PC Units Due to Communication Errors
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