CanadaSolar™ GI systems (Lot/serial 24710569; model/catalogue G3-8) from Laborie Medical Technologies, Corp., specifically units with water perfusion capabilities, are affected. Moisture can accumulate inside internal tubing, the hydrophobic filter, and pressure sensors or enter the air compressor, causing inaccurate pressure readings and excess fluid delivery that can lead to patient water intoxication. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Laborie Medical Technologies, Corp., 180 International Dr., Portsmouth, New Hampshire, United States, 03801.
How to identify it
Affected products: Solar™ GI; Lot or serial number: 24710569; Model or catalogue number: G3-8
The hazard
Under extended clinical use conditions (e.g., long-duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter (part of MPP T/PC tubing set) and pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed. Water ingress in the air compressor can cause inaccurate pressure readings, resulting in excess fluid being administered to the patient than what is indicated by the system, which can lead to patient water intoxication. The issue is only related to Solar GI systems that have water perfusion capabilities.
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)