Eclipse™ Pro and Eclipse™ Mini
Brand(s)
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
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