Fabian HFO and fabian Therapy evolution (2018-12-18)
- Starting date:
- December 18, 2018
- Posting date:
- December 28, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68728
Affected products
- Fabian HFO
- fabian Therapy Evolution
Reason
Several design failures may cause the ventilators to operate differently than expected. Under the worst circumstances, this may result in the patient not receiving breath support.
Affected products
A. Fabian HFO
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
7200
Companies
- Manufacturer
-
Acutronic Medical Systems AG
Fabrik im Schiffli
Hirzel
8816
SWITZERLAND
B. fabian Therapy Evolution
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
7250.N
Companies
- Manufacturer
-
Acutronic Medical Systems AG
Fabrik im Schiffli
Hirzel
8816
SWITZERLAND