Z-2829-2018 Class II
FDA device recall Z-2829-2018 was initiated by Withings Sas on June 11, 2018 and is designated Class II. Reason for recall: Device could not meet the requirements for systolic pressure Affected quantity: Total 44,000 units (15,139 US/ 28,861 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- June 11, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 44,000 units (15,139 US/ 28,861 OUS)
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
Distribution Pattern
US Nationwide Distribution
Code Information
7024260310