Health product recall

A.T.S.® 5000TS (Tourniquet System) With Hoses And Lop Sensor (Personalized Pressure)

Last updated

Summary

Product
A.T.S.® 5000TS (Tourniquet System) With Hoses And Lop Sensor (Personalized Pressure)
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
A.T.S.® 5000TS (Tourniquet System) With Hoses And Lop Sensor (Personalized Pressure) More than 10 numbers, contact manufacturer. 60500010100

Issue

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Zimmer Surgical, Inc. Also Trading As Relign Corporation

200 W Ohio Avenue, Dover, Ohio, United States, 44622

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81483

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