Withings recalls Scan Monitor/ScanWatch model hwa09 wrist watches that record heart activity (ECG) due to a software bug eliminating initial ECG activation and review under physician care. The device is only cleared for use with medical supervision.
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.
Withings is recalling its Scan Monitor/ScanWatch hwa09 model wrist watches that record heart activity (ECG) and oxygen saturation. A software bug has eliminated the initial ECG activation and review under a physician's care, which is required for safe use. This device is only cleared for use under medical supervision.
The software bug prevents the device from properly activating and reviewing ECG data under a physician's care. Since the device is only cleared for use with medical supervision, this issue could lead to incorrect health readings if used without proper oversight.
Users of the Withings Scan Monitor/ScanWatch hwa09 model (wrist watches that record heart activity and oxygen saturation) are affected. The device is intended for use under medical supervision, so individuals who rely on it for health monitoring without a physician's oversight are at risk of inaccurate readings.
Check for the model number hwa09 on the device. The product is a Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2). Serial numbers listed in the recall include: 00:24:e4:e6:94:a0, 00:24:e4:ee:d6:a3, 00:24:e4:ef:3d:52, and others.
Look for the model number hwa09 on your Withings Scan Monitor/ScanWatch wrist watch.
Reach out to Withings customer support for guidance on next steps.
The device is only cleared for use under medical supervision. The software bug may prevent proper ECG activation and review, so it should not be used without a physician's oversight.
Check if your device has the model number hwa09. If so, contact Withings customer support for instructions.
No, the device should not be used without a physician's oversight due to the software bug affecting ECG activation and review.
We’ve drafted a message you can send Withings to request your refund or repair — edit it as you like.
Subject: Recall Z-1280-2023 — Withings Withings Hello, I own a Withings that is covered by recall Z-1280-2023 from Withings. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
