Health product recall

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

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

IMRIS iMRX System

Lot or serial number

153374

Model or catalog number

10094141

Companies
Manufacturer

Deerfield Imaging, Inc.

5101 Shady Oak Road

Minnetonka

55343

Minnesota

UNITED STATES