Recall Z-0689-2018 ยท FLL Continuous Measurement Thermometer
Philips Consumer Lifestyle
Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
| Date | Feb 22, 2018 (initiated Feb 2, 2018) |
| Status | Terminated |
| 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100488 | IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 Shenzhen Dongdixin Technology Co., Ltd., Jul 22, 2010 |