Health product recall

Fabian HFO (2021-07-26)

Starting date:
July 26, 2021
Posting date:
August 24, 2021
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-76289



Last updated:
2021-08-24

Affected Products 

  • A. Fabian HFO
  • B. Fabian Therapy evolution

Reason

Multiple issues representing software anomalies.

Affected products

A. Fabian HFO

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number
  • 111001
  • 111001.01
  • 112001
  • 113001
  • 7200
  • 7200.I
  • 7201
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
  • 121001
  • 121012
  • 7250.N
Companies
Manufacturer

Acutronic Medical Systems AG

Fabrik im Schiffli

Hirzel

8816

SWITZERLAND