Recall Z-1796-2015— Mortara Instrument, Inc

Name: FDA recall Z-1796-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-29

Class II · Terminated

Class II FDA medical device recall by Mortara Instrument, Inc, initiated 2015-05-29, terminated 2015-08-05. It names one FDA 510(k) clearance: K142105. 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.. 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: Mortara Instrument, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Terminated: 2015-08-05
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K142105 — ELI 380 ELECTROCARDIOGRAPHMortara Instrument, Inc.·cleared 2014-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.