Mortara ELI 380 Electrocardiograph Recalled for Patient Data Mismatch Risk
Mortara Instrument is recalling 176 ELI 380 electrocardiographs because ECG waveforms may be incorrectly associated with the wrong patient's demographics when transmitted to records systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a risk of harm (misattribution of medical data) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Mortara Instrument, Inc. is recalling 176 units of the ELI 380 Electrocardiograph. The device is a high-performance, multichannel resting electrocardiograph intended for use in hospitals, medical clinics, and offices. The recall is due to a potential safety hazard where, 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.
The affected units were distributed worldwide, including in the United States (AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA, and WI) and in various international locations. The source text does not specify the number of reported illnesses or injuries associated with this defect.
Healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to Mortara Instrument, Inc. for evaluation or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Mortara Instrument, Inc
- Affected units
- 176
Distribution
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