Reported May 6, 2020 · Terminated
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI…
Welch Allyn, Inc/mortara
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WELCH ALLYN, INC/MORTARA · 7865 N 86th St · Milwaukee, WI · 53224-3431
Is this the product you have?
- Lead diagnostic electrocardiograph
- under the following device names
ELI 10ELI 350ELI 150cELI 250cELI 230ELI 280ELI 380R-Scribe and Connex Cardio
- Product UsageA non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms
- Lot codes and dates
- Model Numbers
ELI10-XXX-XXXXXELI350-XXX-XXXXXELI150C-XXX-XXXXXELI250C-XXX-XXXXXELI230-XXX-XXXXXELI280-XXX-XXXXXELI380-XYYZZRSCRIBE-xxx-xxxxx and CC-XXX-XXXX
- Model Numbers
- Amount recalled
- 78,521 units total
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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