Health product recall

Infinity M500 Docking Station

Last updated

Summary

Product
Infinity M500 Docking Station
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 catalog number

Infinity M500 Docking Station

More than 10 numbers, contact manufacturer.

MS20407

Issue

Draeger Medical Systems, Inc. has become aware during testing in conjunction with global market surveillance activities that the Infinity M500 Docking Station is not in full compliance to type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards.

The only ports that could be affected are: Hemo port (gray color), SpO2 port (blue color) and Temp port (white color) on M540. The specific accessories which can be connected to these ports and may be affected are the Dual Hemo MCable, SpO2 MCables, and temperature probes, respectively. 

Recall Start Date: April 15, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Draeger Medical Systems, Inc.

3135 Quarry Road, Telford, Pennsylvania, United States, 18969

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75824

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