Health product recall

Eclipse™ Pro and Eclipse™ Mini

Last updated

Summary

Product
Eclipse™ Pro and Eclipse™ Mini
Issue
Medical devices - Labelling and packaging
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

Eclipse™ Mini Diagnostic Patch Recorder

More than 10 numbers, contact manufacturer.

98900

Eclipse™ Pro Ambulatory ECG And Patch Recorder

More than 10 numbers, contact manufacturer.

98700

Issue

Eclipse™ Pro 98700 and Eclipse™ Mini 98900 devices may have mismatched serial numbers between the label and what is programmed in the devices. This is due to a process error on the manufacturing line, which has resulted in an incorrect serial number being set in a small number of the devices. We are notifying all customers using the devices and providing guidelines to ensure this mismatch does not result in any unreasonable risk.

Recall start date: December 27, 2024

Additional information

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

Spacelabs Healthcare Ltd.

Unit B, Foxholes Centre, Hertford, Hertfordshire, Great Britain, SG13 7DT

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76808

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe