Recall Z-2829-2018 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Withings Sas
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
| Date | Jun 11, 2018 |
| Status | Completed |
| Reason | Device could not meet the requirements for systolic pressure |
| Root cause | 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 t |
| Quantity | Total 44,000 units (15,139 US/ 28,861 OUS) |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133125 | WITHINGS BLOOD PRESURE MONITOR Withings, Mar 24, 2014 |