CanadaSentinel V11 (Sentinel Cardiology Information Managment System) version 11.6.0 (model/catalogue 98201) is affected. Spacelabs Healthcare identified two issues in version 11.6.0 that can associate incorrect patient demographics with reports and assign resting and rhythm reports to the wrong patient, potentially resulting in inaccurate diagnoses and compromised patient safety. Users of software version 11.6.0 should contact their local Spacelabs Healthcare representative to update to version 11.6.1 or contact the manufacturer for more information.
What's being recalled
Companies: Spacelabs Healthcare Ltd. (Hertford), Unit B, Foxholes Centre, Hertford, Hertfordshire, United Kingdom, SG13 7DT.
How to identify it
Affected products: Sentinel V11 (Sentinel Cardiology Information Managment System); Lot or serial number: Version 11.6.0; Model or catalogue number: 98201
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)