Health product recall

Fabian HFO and Fabian +nCPAP Evolution Ventilators (2020-10-05)

Starting date:
October 5, 2020
Posting date:
October 20, 2020
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-74147

Last updated: 2020-10-20

Affected Products

Fabian HFO and Fabian +nCPAP Evolution Ventilators

Reason

Ventilator can experience a malfunction associated with over-delivery of peak-inspiratory pressure with delayed or absent alarm during use of the volume guarantee (VG) function.

Affected products

Fabian HFO and Fabian +nCPAP Evolution Ventilators

Lot or serial number

SN # AI-01042
SN # AI-01050
SN # AI-01701
SN # AI-01702

Model or catalog number

113001
7200.I
7640140860008

Companies
Manufacturer
Acutronic Medical Systems AG
Fabrik im Schiffli
Hirzel
8816
SWITZERLAND