Recall Monitor
Health Products

IMRIS Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Neuro III-SV Intra-Operative MRI System - Main UnitM00106105048-000
Neuro III-SV Intra-Operat. MRI Syst.- Or-Dr-Or Config (With Rotat. Magnet)1001700105117-004
iMRX System- V1M-00026105828-000
iMRI 3T S1093-01116118-000

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.

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