Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0689-2018Class II

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

Philips Consumer Lifestyle B.V. / initiated 2018-02-02 / Terminated

Philips Consumer Lifestyle began a recall of Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) on . FDA classified it as Class II and gives the reason as "Device may provide inaccurate measurements". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0689-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips Consumer Lifestyle B.V.
Product
Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
Product code
FLL Continuous Measurement Thermometer
Reason for recall
Device may provide inaccurate measurements.
FDA 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 in commerce
45141
Distribution
Domestic (2463 units) and Foreign (42678 units)
Product codes and lots
Model Numbers: SCH740 and DL8740 - All lots

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0689-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0689-2018Class IITerminatedVoluntary: Firm initiated