Lead diagnostic electrocardiograph under the following… recallZ-1810-2020 · Welch Allyn, Inc/Mortara · initiated Mar 18, 2020
Class II Terminated All recalls posted in April 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Welch Allyn, Inc/Mortara or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1810-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 18, 2020
- Posted by the FDA
- Apr 29, 2020
- Recalling firm
- Welch Allyn, Inc/Mortara
- Quantity
- 78,521 units total
- Product code
- DPS
- FDA submissions
- K092663, K100127, K101115, K101403, K102206
- 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.
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K092663, K100127, K101115, K101403, K102206 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ELI 230 BUR230-AMortara Instrument, Inc. · Electrocardiograph1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 85297).
- Z-1811-2020 · TerminatedELI 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-1815-2020 · TerminatedS4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF …
- Z-1817-2020 · TerminatedQ-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wire…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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