This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

A) Programmer Application Software 2868 B) Latitude Secure Server

Starting date:
January 20, 2012
Posting date:
January 23, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Identification number:
RA-68316

Reason

A measured shock lead impedance that is greater than 125 Ohms or less than 20 Ohms will generate an alert message and a red alert. However, the value is not displayed on screen. Because of that some physicians think that their leads are defective which is not necessarily the case.

Affected products

A) Programmer Application Software 2868 B) Latitude Secure Server

Lot or serial number

A) N/A B) N/A

Model or catalog number

A) 2868 V1.04, 2868 V1.05 B) 6441

Companies

Manufacturer
Cardiac Pacemakers Incorporated