Health product recall

IMRIS Systems

Last updated

Summary

Product
IMRIS Systems
Issue
Medical devices - Performance
What to do

Customers to be notified of this issue, with instructions and inspections to follow. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Neuro III-SV Intra-Operative MRI System - Main Unit

M00106

105048-000

Neuro III-SV Intra-Operat. MRI Syst.- Or-Dr-Or Config (With Rotat. Magnet)

1001700

105117-004

iMRX System- V1

M-00026

105828-000

iMRI 3T S

1093-01

116118-000

Issue

This recall is being initiated to address a notification received by IMRIS Imaging, Inc. from Siemens regarding the venting paths of IMRIS systems that utilize a 3T siemens magnet (Verio, Skyra). The legal manufacturer of noted magnets is Siemens, see Siemens recall #RA-77988.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Imris Imaging, Inc.
1230 Chaska Creek Way, Chaska, Minnesota, United States, 55318
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78233

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