Health product recall

CAPNOSTAT 5 mainstream sensor CO2 sensor, Respironics LoFlo sidestream CO2 module (2019-02-28)

Starting date:
February 28, 2019
Posting date:
March 22, 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-69376

Affected Products

  • A. CAPNOSTAT 5 mainstream sensor CO2 sensor
  • B. Respironics LoFlo sidestream CO2 module

Reason

Philips has received complaints that the sensor cable for the Philips Respironics CAPNOSTAT 5 mainstream sensor and Respironics LoFlo sidestream sensor may appear kinked or twisted after use. Twisted, coiling and bending of the sensor cables can occur during use, maintenance and storage of the sensors. Such deformation is not itself expected to affect the normal operation of the sensors. However, cables that may have been repeatedly twisted, coiled or bent could cause the sensors to lose functionality and become inoperable.

Affected products

A. CAPNOSTAT 5 mainstream sensor CO2 sensor

Lot or serial number
  • SN 339374
  • SN 345999
Model or catalog number
  • 1015928
Companies
Manufacturer
Respironics Novametrix, LLC
5 Technology Dr.
Wallingford
06492
Connecticut
UNITED STATES

B. Respironics LoFlo sidestream CO2 module

Lot or serial number
  • SN 163-067020
  • SN 163-073492
Model or catalog number
  • 1022054
Companies
Manufacturer
Respironics Novametrix, LLC
5 Technology Dr.
Wallingford
06492
Connecticut
UNITED STATES