Recall Z-1810-2020 ยท DPS Electrocardiograph
WELCH ALLYN, INC/MORTARA
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.
| Date | Apr 29, 2020 (initiated Mar 18, 2020) |
| Status | Terminated |
| Reason | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. |
| Root cause | Device Design |
| Action | Welch Allyn notified customers on 2/19/2020 via "Voluntary Medical Device Correction Welch Allyn Patient Cables or Lead Sets". The recall letter identified the affected product and stated the reason for the recall. The firm also requested the distributors to immediately notify accounts if the product was further distributed. |
| Quantity | 78,521 units total |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092663 | ELI 350 ELECTROCARDIOGRAPH Mortara Instrument, Inc., Dec 14, 2009 |
| K100127 | ELI 230 ELECTROCARDIOGRAPH Mortara Instrument, Inc., Apr 16, 2010 |
| K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 Mortara Instrument, Inc., Jun 18, 2010 |
| K101403 | ELI 250 ELECTROCARDIOGRAPH Mortara Instrument, Inc., Jul 2, 2010 |
| K102206 | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 Mortara Instrument, Inc., Feb 18, 2011 |