Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2266-2015·Announced 2015-08-05

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category: Medical Device — Patient Monitoring
Hazard: mis-labeling
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

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · mis labeling