Health product recall

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

  1. Fabian HFO
  2. 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