Health product recall

ELI280 Resting Electrocardiograph (2021-09-17)

Starting date:
September 17, 2021
Posting date:
October 21, 2021
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-76697

Last updated: 2021-10-22

Affected Products

ELI280 Resting Electrocardiograph

Reason

Following the receipt of a complaint from an end user, Welch Allyn has identified that a software fault exists on the ELI 280 software which may lead to one of the following transmission errors:

1. A specific sequence of operator inputs can lead to the transmission of a different ECG record than the record intended to be transmitted into an electronic medical record (EMR) system.
2. A Specific sequence of operator inputs could cause patient exam demographics to be incorrectly attached to the Waveform of another patient and be printed or transmitted into an EMR system.  Software fix/update to be installed to correct this software fault.  Hillrom can confirm there have been no reports of any harm during the estimated 202 million patient experiences, however Hillrom is conducting this field safety corrective action to correct the software and therefore prevent the above potential scenarios from occurring.

Affected products

ELI280 Resting Electrocardiograph

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

BUR280
ELI280

Companies
Manufacturer
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES