No image published for this recall

No image published for this recall

Eclipse™ pro and eclipse™ mini

Official notice

8 Jan 2025

Last checked

8 Jan 2025

Medium riskHealth Canada

An official Health Canada notice concerns Eclipse™ pro and eclipse™ mini. 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 Published 2025-01-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76808

Official notice

2025-01-08

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76808

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Affected products

Product 1

Affected products - Eclipse™ Mini Diagnostic Patch Recorder, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 98900

Product 2

Affected products - Eclipse™ Pro Ambulatory ECG And Patch Recorder, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 98700

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Spacelabs Healthcare, MINI.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76808

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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