CanadaThe Philips IntelliSpace Critical Care and Anesthesia (ICCA) software, releases J.06.01 and J.06.02 (VERSION J.06), is affected only for customers who have configured and use Auto Charting for Infusion Data for a Clinical Unit with either automatic periodic charting of infusion rates and volumes or automatic aperiodic charting of infusion rates and bolus volumes when a change occurs. 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; contact the manufacturer for additional information.
What's being recalled
Companies: Philips Medizin Systeme Boblingen GmbH, Hewlett-Packard Strasse 2, Boblingen, Germany, 71034.
How to identify it
Affected products: IntelliSpace Critical Care And Anesthesia; Lot or serial number: Not applicable.; Model or catalogue number: VERSION J.06
The hazard
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.
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)