Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (2021-03-05)

Starting date:

March 5, 2021

Posting date:

May 6, 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-75523

Last updated: 2021-05-06

• Reason
• Affected products

Produits Touchés

Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console

Reason

As a result of customer complaints, an issue was identified with a direct current to direct current (DC-DC) converter used within the system controller module of the Bio-Console 560 instrument. The issue has resulted in nine complaint occurrences related to issues with device performance including: the user interface not working, the instrument shutting down (no pump rotation), smoking and burning smell prior to and during use.

Affected products