Welch Allyn Electrocardiographs Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling 78,521 lead diagnostic electrocardiographs because they may not meet defibrillation withstand requirements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may fail to meet safety standards for defibrillation withstand, posing a risk of harm to patients or operators, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Welch Allyn, Inc/Mortara is recalling 78,521 units of lead diagnostic electrocardiographs, including models ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe, and Connex Cardio. These non-invasive prescription devices are indicated for use to acquire, analyze, display, transmit, and print electrocardiograms.
The recall was initiated because the impacted products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. This standard ensures that medical electrical equipment can withstand defibrillation without causing harm to the patient or operator.
The affected units were distributed nationwide in the United States, including the District of Columbia, Puerto Rico, and Ontario. Consumers and healthcare providers should identify their device model numbers and contact Welch Allyn for further instructions on the recall.
The recalled product
- Product
- 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 pri
- Manufacturer
- WELCH ALLYN, INC/MORTARA
- Affected units
- 78,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
Part of a larger recall action
This product is one of 10 recalled by WELCH ALLYN, INC/MORTARA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · WELCH ALLYN, INC/MORTARA
See all →- HighELI 280 Resting Electrocardiographs Recalled Due to Device Malfunction
FDA (Devices) · 2021-10-13
- ModerateWelch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance
FDA (Devices) · 2021-04-28
- ModerateWelch Allyn AM12M Acquisition Module Recalled for IEC 60601-2-27 Non-Compliance
FDA (Devices) · 2021-04-28
- ModerateWelch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance
FDA (Devices) · 2021-04-28
- ModerateWelch Allyn ELI 280 Electrocardiograph Recalled for Safety Standard Non-Compliance
FDA (Devices) · 2021-04-28
Same hazard · electrical safety
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- ModerateSpacelabs SL Command Module patient monitor recall due to manufacturing defect
FDA (Devices) · 2026-05-13
- High
- High
- ModerateMRI systems recalled over electrode spacing below the required safety standard
FDA (Devices) · 2025-11-05