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Expression MRI Patient Monitoring System-Main Unit (2015-05-07)
- Starting date:
- May 7, 2015
- Posting date:
- June 1, 2015
- 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-53531
Recalled Products
- Expression MRI Patient Monitoring System-Main Unit
Reason
Philips has become aware that recent revisions of the device's Instructions for Use (IFU) (part number 989803162691, rev. F- rev. H) inaccurately indicate "endotracheal" as a body temperature application site. The FlexTemp reusable temperature sensor is not intended to be used for endotracheal site placement.
Affected products
A. Expression MRI Patient Monitoring System-Main Unit
Lot or serial number
All lots.
Model or catalog number
865214
Companies
- Manufacturer
-
Invivo, a Div. of Philips Medical Systems
12151 Research Parkway
Orlando
32826
Florida
UNITED STATES