Recall Z-0689-2018— Philips Consumer Lifestyle

Name: FDA recall Z-0689-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-02

Class II · Terminated

Class II FDA medical device recall by Philips Consumer Lifestyle, initiated 2018-02-02, terminated 2019-03-29. It names one FDA 510(k) clearance: K100488. Product: Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740). Reason: Device may provide inaccurate measurements..

Recalling firm: Philips Consumer Lifestyle
Classification: Class II
Status: Terminated
Initiated: 2018-02-02
Terminated: 2019-03-29
Firm location: Stamford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K100488 — IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081Shenzhen Dongdixin Technology Co., Ltd.·cleared 2010-07-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Device may provide inaccurate measurements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.