PneumoClear (2018-10-18)
- Starting date:
- October 18, 2018
- Posting date:
- March 8, 2019
- 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-69238
Affected Products
PneumoClear
Reason
Under certain circumstances the PneumoClear CO2 conditioning insufflator will not detect automatically when the fluid used to humidify the insufflation gas is completely used. As a result the displayed humidification status will be incorrect. This can occur with the heated humidified tube set and the heated humidified smoke evacuation tube set.
Affected products
PneumoClear
Lot or serial number
All serial numbers.
Model or catalog number
- 620050000
- 620050050
- FM300
Companies
- Manufacturer
-
W.O.M. WORLD OF MEDICINE GmbH
SALZUFER 8
BERLIN
10587
GERMANY