Recall MonitorHealth Products
Eclipse™ Pro and Eclipse™ Mini
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
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
Recall class: Type II
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