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Health & beauty Canada Health product recall

IMRIS Systems

What's being recalled

Companies: Imris Imaging, Inc., 1230 Chaska Creek Way, Chaska, Minnesota, United States, 55318.

How to identify it

Affected products: Neuro III-SV Intra-Operative MRI System - Main Unit; Lot or serial number: M00106; Model or catalogue number: 105048-000

Affected products: Neuro III-SV Intra-Operat. MRI Syst.- Or-Dr-Or Config (With Rotat. Magnet); Lot or serial number: 1001700; Model or catalogue number: 105117-004

Affected products: iMRX System- V1; Lot or serial number: M-00026; Model or catalogue number: 105828-000

Affected products: iMRI 3T S; Lot or serial number: 1093-01; Model or catalogue number: 116118-000

The hazard

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.

What to do

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

The official notice

This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.

Read the official notice (opens in a new tab)

A little guidance

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