FDAMarch 18, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

welch allyn inc mortarawelchwelch allyn

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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