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Field Safety Notice

Philips Consumer Lifestyle

FSN FCO #: PHS_Venice_Field_Action_012018

URGENT - Field Safety Notice

Philips Ear Thermometer DL8740 and Philips AVENT Smart Ear

Thermometer SCH740 sold through retailers online and in-store

Important information regarding inaccurate measurements and the risk associated

with relying on the Thermometer as the sole basis for a decision seeking treatment

and/or professional help

All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means,

electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.

02-02-2018

Dear Customer,

A concern has been identified regarding the information provided with the Philips Ear Thermometer (DL8740)

and Philips AVENT Smart Ear Thermometer (SCH740) (“Device”), that if it were to materialize, could pose

risks for people being measured (‘Patient’).

This Field Safety Notice is intended to inform you about:

 what the concern is and under what circumstances these risks can occur;

 the actions that should be taken by the users of the Device in order to prevent risks to Patients;

 the actions planned by Philips to mitigate the risks.

This document contains important information for the continued safe and proper

use of the Device.

Please review the following information and share with all the users of the Device. It is important to

understand the implications of this communication. Please retain a copy of this Field Safety Notice with the

instructions for use of the Device.

Philips has become aware of a number of complaints related to possible inaccurate measurements by the

Device. Philips has identified that the risk of delaying treatment can have serious consequences for

newborns (0-3 months), small children (4-36 months) and Patients of any age that may not be able to

communicate and take care of themselves. In case a measurement shows a normal temperature value

whereas the Patient actually has a fever, then that inaccurate measurement might lead to delayed or

improper treatment of an underlying medical condition such as infection, which could result in Patient injury.

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