Health product recall

Collision Ring System on IMRIS iMRI 3T S (2018-04-04)

Starting date:
April 4, 2018
Posting date:
May 11, 2018
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-66742

Affected products

Collision Ring System on IMRIS iMRI 3T S

Reason

Deerfield Imaging, Inc. has initiated a product correction for the collision ring detection system on the IMRIS iMRI 3T S systems (Skyra Magnets). There is a potential performance issue where the collision detection ring system may not detect a collision with the perimeter of the MRI bore and the stationary table and patient.

Affected products

Collision Ring System on IMRIS iMRI 3T S

Lot or serial number

10093-01

Model or catalog number

10093-01

Companies
Manufacturer

DEERFIELD IMAGING, INC

5101 SHADY OAK ROAD,

MINNETONKA

55343

UNITED STATES