Mortara Instrument, Inc recalls ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph.…

Recall date

May 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1796-2015

FDA classification

Class II

Brand / firm

Mortara Instrument, Inc

Sold / distributed

Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA and WI., and to the countries of : CHINA, PORTUGAL, CANADA, OMAN, MALAYSIA, NEW ZEALAND, INDIA, POLAND, LEBANON, SWITZERLAND, FINLAND, ROMANIA,UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, THE NETH…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.