Welch Allyn ELI PC Service Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling ELI PC Service software because it may not meet defibrillation withstand safety requirements for medical electrical equipment.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Welch Allyn, Inc/Mortara is recalling the ELI PC Service software. This service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files. The recall involves 78,521 units distributed nationwide in the United States, including specific states and territories listed in the agency notice.
The recall was initiated because the impacted products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25, which is the standard for Medical Electrical Equipment. This non-compliance poses a potential safety risk related to defibrillation withstand capabilities.
The affected model numbers are 11066-XXX-50 and 41000-029-XX. Users of this software should contact Welch Allyn for further instructions on how to address the safety issue.
The recalled product
- Product
- ELI 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.
- Manufacturer
- WELCH ALLYN, INC/MORTARA
- Category
- Medical Device — ECG Software
- 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 (2)
- Model Numbers: 11066-XXX-50
- 41000-029-XX.
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.
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