IMRIS Systems
Brand(s)
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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