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Recall Observatory FDA recall evidence

Device 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.

Z-1811-2020

March 18, 2020

Class II

Product summary

Firm
WELCH ALLYN, INC/MORTARA
Event
Event 85297
Status
Terminated
Classification
Class II
Quantity
78,521 units total
Official record key
device-enforcement:Z-1811-2020

Official wording

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

Code information: Model Numbers: 11066-XXX-50, 41000-029-XX.

Distribution pattern: US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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