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