IMRIS Systems recall in Canada: Performance issue
In plain language
This recall involves IMRIS Systems medical devices sold in Canada. They are being recalled due to a performance issue related to the venting paths of the systems. Healthcare customers should follow the instructions and inspections provided in the official notice.
What to do
- Customers will be notified of this issue.
- Follow the instructions and inspections provided.
- Contact IMRIS Imaging, Inc. for more information.
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Affected products
Neuro III-SV Intra-Operative MRI System - Main Unit
Model: 105048-000
Lot: M00106
Neuro III-SV Intra-Operat. MRI Syst.- Or-Dr-Or Config (With Rotat. Magnet)
Model: 105117-004
Lot: 1001700
iMRX System- V1
Model: 105828-000
Lot: M-00026
iMRI 3T S
Model: 116118-000
Lot: 1093-01
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 1001700, 1093-01, M-00026, M00106
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 105048-000, 105117-004, 105828-000, 116118-000
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves IMRIS Systems medical devices sold in Canada. They are being recalled due to a performance issue related to the venting paths of the systems. Healthcare customers should follow the instructions and inspections provided in the official notice.
What should consumers do?
Customers will be notified of this issue. Follow the instructions and inspections provided. Contact IMRIS Imaging, Inc. for more information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on October 7, 2025.
Is the Imris Imaging, Inc. brand affected by this recall?
Yes, Imris Imaging, Inc. products are affected by this recall. This recall involves IMRIS Systems medical devices sold in Canada. They are being recalled due to a performance issue related to the venting paths of the systems. Healthcare customers should follow the instructions and inspections provided in the official notice.