Philips Invivo Expression MRI Patient Monitoring System Labeling Recall
Philips is recalling 697 MRI patient monitoring systems because the labeling inaccurately lists endotracheal as a valid body temperature application site for the FlexTEMP sensor.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error that could lead to incorrect usage of a medical device. It fits the 'Moderate' criteria as it is a labeling issue without reported injuries or deaths, but carries a risk of improper application.
Plain-English summary
Philips Electronics North America Corporation is recalling 697 Invivo Expression MRI Patient Monitoring Systems. The recall addresses a labeling error on devices equipped with the FlexTEMP reusable temperature option. The device labeling inaccurately indicates 'Endotracheal' as a body temperature application site, but the FlexTEMP sensor is not intended for endotracheal placement. The correct application site is Esophageal.
The affected devices are Model Number 865214 with serial numbers ranging from US31204918 through US42708744, specifically those with the FlexTEMP reusable temperature option installed. Devices without this temperature option are not affected. The recall covers units distributed worldwide, including the United States and numerous international markets.
Healthcare facilities should verify if they possess affected devices by checking the model number and serial number against the provided list. If a device is affected, the labeling should be corrected to reflect that the FlexTEMP sensor is intended for Esophageal placement only, not Endotracheal placement.
The recalled product
- Product
- Invivo Expression MRI Patient Monitoring System.
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- Affected units
- 697
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- US31204919
- US31204920
- US31204924
- US31204925
- US31204926
- US31204927
- US31204928
- US31204929
- US31204930
- US31204931
- US31204933
- US31204935
- US31204943
- US31204944
- US31204945
- US31204946
- US31204950
- US31204951
- US31204952
- US31204956
Distribution
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