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.
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: "The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached."
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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Similar recalls
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