Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0689-2018 · Posted 2018-02-22

Recalling FirmPhilips Consumer Lifestyle
Recall StatusTerminated
Product CodeFLL
Date Initiated2018-02-02
Date Terminated2019-03-29
Product Quantity45141

Reason for Recall

Device may provide inaccurate measurements.

Firm 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

Root Cause

Use error

Distribution Pattern

Domestic (2463 units) and Foreign (42678 units)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100488IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081Shenzhen Dongdixin Technology Co., Ltd. · 2010-07-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑