medical Class II Updated 2020-05-06

WELCH ALLYN, INC/MORTARA recalls Lead diagnostic electrocardiograph under the following devic

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Model Numbers: ELI10-XXX-XXXXX, ELI350-XXX-XXXXX, ELI150C-XXX-XXXXX, ELI250C-XXX-XXXXX, ELI230-XXX-XXXXX, ELI280-XXX-XXXXX, ELI380-XYYZZ, RSCRIBE-xxx-xxxxx and CC-XXX-XXXX.

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