FDA recall Z-1280-2023

Product

Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

Reason for recall

A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.

Distribution

Nationwide distribution in the US. No foreign distribution.

Key facts

Status

Ongoing

Initiation date

2022-12-19

Report date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Issy les Moulineaux CEDEX, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1280-2023