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U.S. Department of Health and Human Services

Class 2 Device Recall Avent Smart Ear Thermometer, Philips Ear Thermometer

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  Class 2 Device Recall Avent Smart Ear Thermometer, Philips Ear Thermometer see related information
Date Initiated by Firm February 02, 2018
Date Posted February 22, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0689-2018
Recall Event ID 79158
510(K)Number K100488  
Product Classification Thermometer, electronic, clinical - Product Code FLL
Product Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
Code Information Model Numbers: SCH740 and DL8740 - All lots
Recalling Firm/
Manufacturer		 Philips Consumer Lifestyle
1600 Summer St Fl 5
Stamford CT 06905-5125
For Additional Information Contact Nina Ruiz¿¿
844-531-6861
Manufacturer Reason
for Recall		 Device may provide inaccurate measurements.
FDA Determined
Cause 2		 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)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FLL and Original Applicant = SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
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