Expression MR400 MRI Patient Monitoring System (2020-02-26)

Starting date:

February 26, 2020

Posting date:

March 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72499

Last updated: 2020-03-10

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  Reason
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  Affected products

Affected Products

Expression MR400 MRI Patient Monitoring System

Reason

For MR400 devices with software revisions 01.03.00, 01.04.00, 01.05.00 And 01.07.00, the menu selections for users to access the O2 sensor calibration were changed. These changes were not incorporated into the device's instructions for use. As a result, the instructions for performing the O2 sensor calibration are incorrect for customers performing this task with an MR400 device with these software revisions.

Affected products