CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
What this means for you
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 involves a medical device with a potential risk of power loss to the user interface, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CareFusion is recalling the AVEA Ventilator, a continuous ventilator intended to mechanically control or assist patient breathing. The recall involves 922 units total, with 501 units distributed in the United States and the remainder distributed worldwide in various countries.
The recall is due to a potential risk associated with an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board. This fuse may fail or blow, which could cause a loss of power to the User Interface Module (UIM).
The recalled product
- Product
- Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 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
Same manufacturer · Carefusion 211 Inc dba Carefusion
See all →- HighCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- SevereCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- CriticalCareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- HighCareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
FDA (Devices) · 2016-06-22
- HighCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
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