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FDA Medical Device Recalls (openFDA)

Philips Consumer Lifestyle: Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

Recall number
Z-0689-2018
Recalling firm
Philips Consumer Lifestyle
Product
Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
Status
Terminated
Initiated
2018-02-02
Posted
2018-02-22
Terminated
2019-03-29
Reason
Device may provide inaccurate measurements.
Root cause
Use error
Action
" 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
Quantity
45141
Distribution
Domestic (2463 units) and Foreign (42678 units)
Lot, serial or model codes
Model Numbers: SCH740 and DL8740 - All lots
510(k) numbers
["K100488"]
PMA numbers
not on file
Product code
FLL
Firm FEI
3009181561
Firm city
Stamford
Firm state
CT
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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