IMRIS iMRX System (2019-11-26)

Starting date:

November 26, 2019

Posting date:

January 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71997

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

IMRIS iMRX System

Reason

It was found that the generator A100 may fail above a specific value due to a tolerance problem in the power supply of the generator control. The result is that the required voltage for the x-ray tube would not be supplied any longer. The issue occurs sporadically. However, it may occur during an on-going procedure which may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. No reports of serious injury or death have been received by the company to date.

Affected products