Health product recall

SenTec Digital Monitoring System V-Sign Membrane Changer (2019-05-07)

Starting date:
May 7, 2019
Posting date:
June 7, 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-70121



Last updated: 2019-06-07

Affected Products

SenTec Digital Monitoring System V-Sign Membrane Changer

Reason

SenTec has initiated a field corrective action to address an issue associated with a manufacturing defect that occurred for certain inserts. Due to a manufacturing issue of the electrolyte cartridge of certain membrane changer inserts, there is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure if a MC with such an insert is used.

Affected products

SenTec Digital Monitoring System V-Sign Membrane Changer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MC-I

MC-R

Companies
Manufacturer

SenTec AG

Ringstrasse 39, Therwil,

Basel land

4106

SWITZERLAND