Withings has issued a voluntary recall of ScanWatch in the US for a limited number of units. The recall was conducted in collaboration with the FDA following the discovery of a software bug that allowed some users to use the ECG feature without the required physician review. Withings is conducting the recall in order to comply with the FDA’s clearance of the device. It turns out that simply updating the app fixes the problem.
How did this catch our attention?
Earlier today a few ScanWatch users in the US received an email from Amazon. It notified them of a “potential safety concern” with the product. The email says that the FDA has informed the retailer that “the product listed may not meet current mandatory or voluntary safety standards”. Even more worryingly, the Amazon communication stated “if you still have this product, we urge you to stop using it immediately”.
Needless to say, this sparked confusion on social media as to the cause of the recall. To coincide with the Amazon email, the FDA published a Class 2 Device Recall. Looking at the documentation, this filing was initiated on December 19th, and only published on March 22nd.
So what’s going on? Luckily, the French-based outfit stepped in right away in to clarify things.
ScanWatch is an FDA-cleared device in the US, under K201456, for use under the care of a physician. Withings provides users access to a physician through its app for the initial ECG activation and review of their results.
Reason for the voluntary recall
The company issued a voluntary recall for ScanWatch due to a software issue caused by a software update on the Withings app for iOS. The bug that occurred on 10/04/2022 prevented the initial ECG activation and review under the supervision of a physician.
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This means that some users were able to use the ECG feature without the required physician review, which is contrary to the approved indications for use cleared under K201456 in the United States. As a result, Withings is conducting the voluntary recall in order to comply with the device’s FDA clearance.
The French outfit says they contacted all the concerned users on December 19th, 2022 (some 1,500 of them). There was a follow-up communication on February 13th. None of these users are in Europe, the UK, Australia, and New Zealand.
Potential issues and resolution
If you were affected by the software bug, you might not be able to use the ECG feature until you update and activate it under the supervision of a doctor. Those who continue to use the device without activating their ECG feature under the supervision of a physician (through the app) may fail to seek medical care or guidance when it is needed, or they may seek medical care when it is not necessary.
How to fix
The fix is very simple. Update the Withings app to version 5.14 or higher and sync your watch. If you were affected by the bug, the software will ask you to activate the ECG feature, as required, through a physician. You’re good to go from that point on.
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