CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling 922 AVEA Ventilators worldwide because an incorrect fuse may fail, causing loss of power to the user interface module.
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 has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface…"
Plain-English summary
CareFusion 211 Inc dba Carefusion is recalling 922 units of the AVEA Ventilator, specifically the Gas Delivery Engine (GDE)-refurbished, R16650A. The recall covers 501 units in the United States and the remainder distributed worldwide to countries including Australia, Canada, Japan, and the United Kingdom.
The recall was initiated because the ventilators contain an incorrect F1 fuse on the Transducer Communication Alarm (TCA) Board. This fuse may fail or blow, which can result in a loss of power to the User Interface Module (UIM). The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Manufacturer
- Carefusion 211 Inc dba Carefusion
- Category
- Medical Device — Ventilator
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Carefusion 211 Inc dba Carefusion under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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