Recall MonitorHealth Products
IntelliSpace Critical Care And Anesthesia
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: IntelliSpace Critical Care And Anesthesia
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| IntelliSpace Critical Care And Anesthesia | Not applicable. | VERSION J.06 |
Issue
In ICCA releases J.06.01 and J.06.02, calculations triggered by infusion-pump auto-charting may result in incorrect Intake Totals, Output Totals, Net Body Balance, Length of Stay (LOS) Balance, and related fluid-balance values.This issue applies only to customers that have configured and use Auto Charting for Infusion Data for a Clinical Unit, with one or both of the following settings enabled:• Automatic periodic charting of infusion rates and volumes.• Automatic aperiodic charting of infusion rates and bolus volumes when a change occurs.Customers that do not have either Auto Charting for Infusion Data setting configured and in use are not impacted by this issue.