Official recall record
Sentinel V11 (Sentinel Cardiology Information Managment System)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-12-17
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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