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