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Incident · Recall

Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review

An iOS app bug (occurred Oct 4 2022) bypassed the K201456-required initial physician-supervised ECG activation/review on the ScanWatch; Withings initiated a recall Dec 19 2022 and the FDA classified it Class 2 on Mar 22 2023. About 1,500 US users were affected; fixed via a Withings app update (v5.14+). A correctable software defect (off-label use of the cleared ECG feature), no injury.

Occurred 2022-12-19 · Withings ScanWatch

Machine-readable surfaces

Sources (2)

  1. Gadgets & Wearables · https://gadgetsandwearables.com/2023/03/23/withings-scanwatch-recall-ecg-issue/
  2. FDA (recall record) · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=198114

Common questions

What happened in Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review?
An iOS app bug (occurred Oct 4 2022) bypassed the K201456-required initial physician-supervised ECG activation/review on the ScanWatch; Withings initiated a recall Dec 19 2022 and the FDA classified it Class 2 on Mar 22 2023. About 1,500 US users were affected; fixed via a Withings app update (v5.14+). A correctable software defect (off-label use of the cleared ECG feature), no injury.
When did this incident occur?
The incident is recorded as occurring on December 19, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review?
Withings ScanWatch is the recorded robot involved in this incident.
Has anyone responded to Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-06-04

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-06-04

Sources by quality tier

1
unclassified
Unclassified source
1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review.

Canonical ID c1338c72-2cea-4c24-b96a-920016a82e01