Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
FDA device recall Z-0689-2018 · posted 2018-02-22 · Terminated
Recall details
- Recalling firm
- Philips Consumer Lifestyle
- Reason for recall
- Device may provide inaccurate measurements.
- Action taken
- " 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
- Status
- Terminated
- Product code
- FLL
- Quantity affected
- 45141
- Distribution
- Domestic (2463 units) and Foreign (42678 units)
- Date initiated
- 2018-02-02
- Date posted
- 2018-02-22
- Date terminated
- 2019-03-29
- Location
- Stamford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 (K100488) | Shenzhen Dongdixin Technology Co., Ltd. | 2010-07-22 |