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