IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part… recallZ-0428-2013 · Innovative Magnetic Resonance Imaging Systems Inc. · initiated Oct 19, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Innovative Magnetic Resonance Imaging Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
FDA root cause category: Labeling design
What the company is doing
Consignees were sent on 10/19/12 a IMRIS "Urgent Medical Device Correction" letter dated October 16. 2012. The letter described the product and the problem involved in the recall. It also provided changes to the Operator's Manual and labeling which addresses the issue. Customers may contact 1-866-475-0525.
Recall details
- Recall number
- Z-0428-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 19, 2012
- Posted by the FDA
- Nov 21, 2012
- Recalling firm
- Innovative Magnetic Resonance Imaging Systems Inc.
- Quantity
- 23
- Product code
- LNH
- FDA submissions
- K061916, K071099, K083137
- Distribution
- Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
Product description
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Code information (models, lots, serial numbers)
10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513
Other devices under the same FDA submission
3 devices cleared under K061916, K071099, K083137 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Neuro III-SV iMRI SystemIMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Neuro III-SV iMRI SystemIMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Neuro II-SE 105000-00XIMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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