Official recall record
Infinity M500 Docking Station
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-07-18
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.