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