Health product recall

HeartStart Intrepid Monitor/Defibrillator

Last updated

Summary

Product
HeartStart Intrepid Monitor/Defibrillator
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Heartstart Intrepid Monitor/Defibrillator

Not applicable.

867172

Issue

When monitoring ECG using either a 5-lead or 10-lead ECG cable, the HeartStart Intrepid Monitor/Defibrillator may display intermittent ECG waveforms when the fourth limb lead is placed on the patient. The ECG tracing is normal when only three limb leads are connected (right arm, left arm, and left leg). However, when there are one or more poor ECG lead connections to the patient, the ECG tracing either displays a dashed line or is intermittent between waveform and dashed line. This failure may occur any time the HeartStart Intrepid Monitor/Defibrillator is being used to monitor a 5-lead or 12-lead ECG.

Recall Start Date: July 9, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Philips Goldway (Shenzhen) Industrial Inc.

No.2 Keji North 3rd Road, Shenzhen, China, 518057

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75852

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