Recall Z-1810-2020— WELCH ALLYN, INC/MORTARA
Class II · Terminated
Class II FDA medical device recall by WELCH ALLYN, INC/MORTARA, initiated 2020-03-18, terminated 2026-02-09. It names 5 FDA 510(k) clearances: K102206, K101403, K101115 and 2 more. Product: Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.. Reason: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment..
- Recalling firm
- WELCH ALLYN, INC/MORTARA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-18
- Terminated
- 2026-02-09
- Firm location
- Milwaukee, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K102206 — ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
- K101403 — ELI 250 ELECTROCARDIOGRAPH
- K101115 — ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
- K100127 — ELI 230 ELECTROCARDIOGRAPH
- K092663 — ELI 350 ELECTROCARDIOGRAPH
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
Reason for recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.