Cardiovascular · 510(k) · 2023
Withings Scan Monitor 2.0
Withings. Cleared by FDA on 23 August 2023 under submission K230812, product code DPS (electrocardiograph). What FDA's record says, in FDA's words.
Device record · K230812
- Device. Withings Scan Monitor 2.0DEVICE
- Company. Withings (FR)COMPANY
- Decision. 23 August 2023, 510(k), substantially equivalent (traditional review); received 24 March 2023DECISION
- Panel. CardiovascularPANEL
- Product code. DPS, ElectrocardiographCODE
- Regulation. 21 CFR 870.2340, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Form Approved: OMB No. 0910-0120 Expiration Date: June 30, 2023 See PRA Statement on last page Name Withings Scan Monitor 2.0 Indications for Use (Describe) The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a two- channel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVR, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician). The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 898 reports filed against devices carrying product code DPS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · DECGPageWriter TC S · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102027
25 September 2026 · Malfunction · PageWriter · Philips Medical Systems · report 1218950-2026-100667
18 September 2026 · Malfunction · Q-Stress · BAXTER HEALTHCARE CORPORATION · report 3006087789-2026-00025
Baxter received a report stating that an exam was done earlier under the wrong patient information. This occurred after patient use. There was no patient injury or death reported with this event.
16 September 2026 · Malfunction · Midmark Digital ECG Plug-In Software Version 10.2.2 · Midmark Corporation · report 1523530-2026-00012
It was reported by 15 customers that they were getting a high heart rate on the ECG. The ECG did not calculate the heart rate correctly due to multiple instances of the ECG Plug-in being opened concurrently. The doctor reviewed the results and no medication was given or harm occurred. The customers were sent the firmware update as they were on the old firmware Plug-in version.
16 September 2026 · Malfunction · Cardiac Workstation · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-101917
It was reported that the heart rate reading is inaccurate. It is unknown if the device was in use on a patient. There was no report of patient or user harm.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DPS, in Cardiovascular, from Withings, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.