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U.S. Department of Health and Human Services

Class 2 Device Recall Blood Pressure Monitor

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  Class 2 Device Recall Blood Pressure Monitor see related information
Date Initiated by Firm June 11, 2018
Create Date August 16, 2018
Recall Status1 Open3, Classified
Recall Number Z-2829-2018
Recall Event ID 80533
510(K)Number K133125  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product Nokia BPM+ Wireless Blood Pressure Monitor

Product System, measurement, blood-pressure, non-invasive
Code Information 7024260310 
Recalling Firm/
Manufacturer		 Withings Sas
2 rue Maurice Hartmann
Issy les Moulineaux France
Manufacturer Reason
for Recall		 Device could not meet the requirements for systolic pressure
FDA Determined
Cause 2		 Component change control
Action Beginning on June 11, 2018, All end-users who have installed a device will be notified of the recall both by a CRM email and a warning content showing in the companion mobile application. End-users who start using the device after the recall initiation date will be notified upon installation by email and app content as well. Retailers, distributors and partners will also be notified. Upon notification of the recall, the users will be presented with the alternative of either choosing to keep their device or send it back and get a refund. If they chose to get a refund, end-users will be asked to fill-out a form to receive a return waybill and get a refund in exchange of their product. Customers having purchased their device from a retailer will be eligible for a refund as well.
Quantity in Commerce Total 44,000 units (15,139 US/ 28,861 OUS)
Distribution US Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = WITHINGS
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