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Health product recall

ELI 380 Electrocardiograph (2015-05-29)

Starting date:
May 29, 2015
Posting date:
August 5, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59702

Affected products

A. ELI 380 Electrocardiograph

Reason

Under certain workflow scenario's 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.

Affected products

A. ELI 380 Electrocardiograph

Lot or serial number

115060244864
115160253238

Model or catalog number

ELI380-ABX11
ELI380-ACX11

Companies
Manufacturer
Mortara Instrument Inc.,
7865 North 86th St.,
Milwaukee
53224
Wisconsin
UNITED STATES