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Sentinel v11 (sentinel cardiology information managment system)

Official notice

17 Dec 2025

Last checked

17 Dec 2025

Medium riskHealth Canada

An official Health Canada notice concerns Sentinel v11 (sentinel cardiology information managment system). Spacelabs Healthcare identified two issues with version 11.6.0 that can result in incorrect patient data being associated with clinical reports, potentially resulting in inaccurate diagnoses and compromised patient safety. Issue A - Incorrect Patient Demographics Issue B - Resting and Rhythm reports assigned to the incorrect patient Users of software version 11.6.0 should contact their local Spacelabs Healthcare representative to update their version of software to 11.6.1. Published 2025-12-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81374

Official notice

2025-12-17

The hazard

Spacelabs Healthcare identified two issues with version 11.6.0 that can result in incorrect patient data being associated with clinical reports, potentially resulting in inaccurate diagnoses and compromised patient safety. Issue A - Incorrect Patient Demographics Issue B - Resting and Rhythm reports assigned to the incorrect patient Users of software version 11.6.0 should contact their local Spacelabs Healthcare representative to update their version of software to 11.6.1.

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.

Skus

98201

Other

RA RA-81374

Model Numbers

98201

Recall Numbers

81374

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Affected products

Product 1

Affected products - Sentinel V11 (Sentinel Cardiology Information Managment System), Lot or serial number - Version 11.6.0, Model or catalogue number - 98201

Product 2

Lot or serial number - Version 11.6.0, Model or catalogue number - 98201

Risk / hazard

Spacelabs Healthcare identified two issues with version 11.6.0 that can result in incorrect patient data being associated with clinical reports, potentially resulting in inaccurate diagnoses and compromised patient safety. Issue A - Incorrect Patient Demographics Issue B - Resting and Rhythm reports assigned to the incorrect patient Users of software version 11.6.0 should contact their local Spacelabs Healthcare representative to update their version of software to 11.6.1.

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.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81374

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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