medical Class II Updated 2020-05-06

WELCH ALLYN, INC/MORTARA recalls ELI PC. The ELI PC Service automatically converts resting EC

Recalled Product

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.

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: 11066-XXX-50, 41000-029-XX.
View official government recall

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