Public recall detail

Sentinel V11 (Sentinel Cardiology Information Managment System)

2025-12-17

medium
Recall Safety notice
Quick summary

Quick summary: Sentinel V11 (Sentinel Cardiology Information Managment System). Date: 2025-12-17.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Sentinel V11 (Sentinel Cardiology Information Managment System). Date: 2025-12-17.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSpacelabs Healthcare Ltd.
ProductSentinel V11 (Sentinel Cardiology Information Managment System)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81374

Affected products

ProductSentinel V11 (Sentinel Cardiology Information Managment System)
LotVersion 11.6.0
Model98201
Serial numberVersion 11.6.0
DescriptionSentinel V11 (Sentinel Cardiology Information Managment System)

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesSpacelabs Healthcare Ltd. (Hertford) Unit B, Foxholes Centre, Hertford, Hertfordshire, United Kingdom, SG13 7DT
Recall date2025-12-10
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81374
Background{}
CompaniesSpacelabs Healthcare Ltd. (Hertford) Unit B, Foxholes Centre, Hertford, Hertfordshire, United Kingdom, SG13 7DT
AudiencesHealthcare
Source updated2025-12-17

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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