Recall Z-2829-2018— Withings Sas

Name: FDA recall Z-2829-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-11

Class II · Completed

Class II FDA medical device recall by Withings Sas, initiated 2018-06-11. It names one FDA 510(k) clearance: K133125. Product: Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive. Reason: Device could not meet the requirements for systolic pressure.

Recalling firm: Withings Sas
Classification: Class II
Status: Completed
Initiated: 2018-06-11
Firm location: Issy les Moulineaux, France

510(k) clearances named in this recall

1 on FDA's record

K133125 — WITHINGS BLOOD PRESURE MONITORWithings·cleared 2014-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Device could not meet the requirements for systolic pressure

Data sourced from openFDA. This site is unofficial and independent of the FDA.