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Recall Observatory FDA recall evidence

Device product

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

Z-2829-2018

June 11, 2018

Class II

Product summary

Firm
Withings Sas
Event
Event 80533
Status
Completed
Classification
Class II
Quantity
Total 44,000 units (15,139 US/ 28,861 OUS)
Official record key
device-enforcement:Z-2829-2018

Official wording

Reason: Device could not meet the requirements for systolic pressure

Code information: 7024260310

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device could not meet the requirements for systolic pressure