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AVEA Ventilator (2015-04-28)
- Starting date:
- April 28, 2015
- Posting date:
- June 10, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53735
Recalled Products
A. AVEA Ventilator
Reason
AVEA ventilators can, over-time, develop a pressure transducer failure where the ventilator activates a false extended high peak or circuit occlusion alarm. This will cause safety value to immediately open and stop device from ventilating. (193 devices/154 spare parts affected)
Affected products
A. AVEA Ventilator
Lot or serial number
All lots.
Model or catalog number
AVEA
Companies
- Manufacturer
-
Carefusion
22745 Savi Ranch Parkway
Yorba Linda
92887
California
UNITED STATES