Atlas FDA

Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

FDA device recall Z-0689-2018 · posted 2018-02-22 · Terminated

Recall details

Recalling firm
Philips Consumer Lifestyle
Reason for recall
Device may provide inaccurate measurements.
Action taken
" Philips advises users of the Device to only use the Device as directed in the instructions for use including the additional advice as per this Field Safety Notice " Philips advises users against relying on the Device as the sole basis for a decision seeking treatment and/or professional help " Users who wish to return the Devices based on the information provided in this Field Safety Notice can contact their local Philips product support representative
Root cause
Use error
Status
Terminated
Product code
FLL
Quantity affected
45141
Distribution
Domestic (2463 units) and Foreign (42678 units)
Date initiated
2018-02-02
Date posted
2018-02-22
Date terminated
2019-03-29
Location
Stamford, CT

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Related 510(k) clearances

RecordFirmDate
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 (K100488)Shenzhen Dongdixin Technology Co., Ltd.2010-07-22