CanadaA.T.S. 5000TS Tourniquet System with hoses and Lop sensor (Personalized Pressure), model/catalogue number 60500010100, and affected lot/serial numbers (more than 10 numbers—contact the manufacturer) is included. It was recalled because the user interface can become corrupted when used in certain international languages (including French) due to insufficient RAM when loading a third font set, which can freeze the screen and require restarting; the device can still be used in English. Contact the manufacturer for additional information.
What's being recalled
Companies: Zimmer Surgical, Inc. Also Trading As Relign Corporation, 200 W Ohio Avenue, Dover, Ohio, United States, 44622.
How to identify it
Affected products: A.T.S.® 5000TS (Tourniquet System) With Hoses And Lop Sensor (Personalized Pressure); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 60500010100
The hazard
Zimmer Biomet is conducting a phased serial specific medical device recall for A.T.S. 5000TS Tourniquet System. Multiple complaints have been received related to the devices in scope indicating that when the device is used in certain international languages (including French), the user interface can become corrupted due to insufficient ram when loading a third font set. This may cause the screen to freeze or stop responding to touch, requiring the device to be restarted.
The affected devices can continue to be used in English language mode which is unaffected.
The defectiveness was discovered on October 28, 2025. Issue was identified through the complaints handling process. There have been 3 reported complaints in Canada regarding 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)