FDA Enforcement
Class II
Completed
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
Recall: Z-2829-2018
·
Reported August 22, 2018
Enforcement
- Recall Number
- Z-2829-2018
- Event ID
- 80533
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Withings Sas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 22, 2018
- Initiation Date
- June 11, 2018
- Classification Date
- August 16, 2018
- Address
- 2 rue Maurice Hartmann, Issy les Moulineaux, N/A, France
Description
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
Reason
Device could not meet the requirements for systolic pressure
Code Info
7024260310
Distribution
US Nationwide Distribution
Quantity
Total 44,000 units (15,139 US/ 28,861 OUS)