FDA Medical Device Recalls (openFDA)
Withings Sas: Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
- Recall number
- Z-2829-2018
- Recalling firm
- Withings Sas
- Product
- Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
- Status
- Completed
- Initiated
- 2018-06-11
- Posted
- not on file
- Terminated
- not on file
- 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 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
- Total 44,000 units (15,139 US/ 28,861 OUS)
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 7024260310
- 510(k) numbers
- ["K133125"]
- PMA numbers
- not on file
- Product code
- DXN
- Firm FEI
- 3012024804
- Firm city
- Issy les Moulineaux
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28