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
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
Expression MR400 MRI Patient Monitoring System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
866185
Companies
- Manufacturer
-
Invivo, a Div. of Philips Medical Systems
12151 Research Parkway
Orlando
32826
Florida
UNITED STATES