Recall Z-1811-2020— WELCH ALLYN, INC/MORTARA

Name: FDA recall Z-1811-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-18

Class II · Terminated

Class II FDA medical device recall by WELCH ALLYN, INC/MORTARA, initiated 2020-03-18, terminated 2026-02-09. It names one FDA 510(k) clearance: K093339. 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.. 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

1 on FDA's record

K093339 — ELI PC ELECTROCARDIOGRAPHMortara Instrument, Inc.·cleared 2010-02-19

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

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.

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.