Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance Recalled by Mortara Instrument, Inc Due to Mortara Instrument, Inc. has recently become aware of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mortara Instrument, Inc directly.
Affected Products
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
Quantity: 176
Why Was This Recalled?
Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system.
Where Was This Sold?
This product was distributed to 11 states: AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA, WI
About Mortara Instrument, Inc
Mortara Instrument, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report