Z-1810-2020 Class II Terminated
FDA device recall Z-1810-2020 was initiated by WELCH ALLYN, INC/MORTARA on March 18, 2020 and is designated Class II. Reason for recall: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. The recall status is terminated (terminated February 9, 2026). Affected quantity: 78,521 units total.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- March 18, 2020
- Termination Date
- February 9, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78,521 units total
Product Description
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
Reason for Recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
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.
Code Information
Model Numbers: ELI10-XXX-XXXXX, ELI350-XXX-XXXXX, ELI150C-XXX-XXXXX, ELI250C-XXX-XXXXX, ELI230-XXX-XXXXX, ELI280-XXX-XXXXX, ELI380-XYYZZ, RSCRIBE-xxx-xxxxx and CC-XXX-XXXX.