Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ELI PC. The ELI PC Service automatically converts resting ECG Recalled by WELCH ALLYN, INC/MORTARA Due to Impacted Welch Allyn products may not meet the...

Date: March 18, 2020
Company: WELCH ALLYN, INC/MORTARA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact WELCH ALLYN, INC/MORTARA directly.

Affected Products

ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.

Quantity: 78,521 units total

Why Was This Recalled?

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About WELCH ALLYN, INC/MORTARA

WELCH ALLYN, INC/MORTARA has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report