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Completed

Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

FDA Recall Z-2829-2018 · Posted None

Recalling FirmWithings Sas
Recall StatusCompleted
Product CodeDXN
Date Initiated2018-06-11
Product QuantityTotal 44,000 units (15,139 US/ 28,861 OUS)

Reason for Recall

Device could not meet the requirements for systolic pressure

Firm 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.

Root Cause

Component change control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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