Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 2
FDA device recall Z-1810-2020 · posted 2020-04-29 · Terminated
Recall details
- Recalling firm
- WELCH ALLYN, INC/MORTARA
- Reason for recall
- Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 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,
- Date initiated
- 2020-03-18
- Date posted
- 2020-04-29
- Date terminated
- 2026-02-09
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 (K102206) | Mortara Instrument, Inc. | 2011-02-18 |
| ELI 250 ELECTROCARDIOGRAPH (K101403) | Mortara Instrument, Inc. | 2010-07-02 |
| ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 (K101115) | Mortara Instrument, Inc. | 2010-06-18 |
| ELI 230 ELECTROCARDIOGRAPH (K100127) | Mortara Instrument, Inc. | 2010-04-16 |
| ELI 350 ELECTROCARDIOGRAPH (K092663) | Mortara Instrument, Inc. | 2009-12-14 |