Recall Monitor
Health Products

Sentinel V11 (Sentinel Cardiology Information Managment System)

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Sentinel V11 (Sentinel Cardiology Information Managment System)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Sentinel V11 (Sentinel Cardiology Information Managment System)Version 11.6.098201

Issue

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.

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