Sentinel V11 (Sentinel Cardiology Information Managment System)
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Sentinel V11 (Sentinel Cardiology Information Managment System) | Version 11.6.0 | 98201 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Spacelabs Healthcare Ltd. (Hertford)
Unit B, Foxholes Centre, Hertford, Hertfordshire, United Kingdom, SG13 7DT
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81374
Get notified
Receive emails about new and updated recall and safety alerts.