Company: Mortara Instrument, Inc
Date of Enforcement Report 6/24/2015
Class lI:
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, 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.
Recall Number Z-1796-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
Mortara Instrument, Inc, Milwaukee, WI on 5/29/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
176
DISTRIBUTION
Nationwide and Internationally
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