Carefusion Recalls Alaris PC Units Due to Communication Errors
Carefusion is recalling Alaris PC unit model 8015 with software version 9.12 due to communication errors when specific monitoring modules are attached.
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 issue is a communication error, and no injuries or illnesses are reported in the source text.
Plain-English summary
Carefusion Corporation is recalling Alaris PC unit model 8015 with software version 9.12. The Alaris PC unit serves as the central programming, monitoring, and power supply component for the Alaris System.
The recall was initiated because Carefusion received reports of a communication error on the affected units when the Alaris EtCO2 module or Alaris SpO2 module is attached. A total of 9,241 units were distributed nationwide in the United States, as well as in Australia and China.
Healthcare facilities and users should contact Carefusion for further instructions regarding the recall and potential remediation of the communication error.
The recalled product
- Product
- 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.
- Manufacturer
- Carefusion Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 9,241
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- unit model 8015 with software version 9.12
Distribution
Distributed nationwide across the United States.
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