Health product recall

Tremoflo C-100 Airwave Oscillometry System (2018-09-10)

Starting date:
September 10, 2018
Posting date:
October 19, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67930

Affected products

Tremoflo C-100 Airwave Oscillometry System

Reason

On given limited number of Tremoflo C-100 Airwave Oscillometry Systems, there may be a mismatch between the hardware configuration and the device calibration factor that can cause a reversal of the flow signal, which may also lead to a reversal of some of the intra-breath parameters calculated by the software.

Affected products

Tremoflo C-100 Airwave Oscillometry System

Lot or serial number

113334
113337

Model or catalog number

TF-C100-CA

Companies
Manufacturer

THORASYS Thoracic Medical Systems Inc.

6560 Esplanade Ave #103

Montreal

H2V 4L5

Quebec

CANADA