Neuro II-SE 105000-00XRecalls & reported problems
IMRIS Imaging, Inc. · Model 105000-00X include the following: 105000-000, OR-MB Configuration 105000-001, OR-DR Config 105000-002, OR-MB-DR Config 105000-003, OR-MB-OR Config 105000-004, OR-DR-OR Config 105119-001, Multi-Room Imaging Suite MR15L Oracle OR-DR 105087-000, Multi Room Imaging Suite, MR15LS OR-DR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857534006929), received between Aug 24, 2026 and Aug 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K061916, K071099); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device1
- Fail-Safe Did Not Operate1
- Failure to Auto Stop1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Device Damaged by Another Device; Failure to Auto Stop; Fail-Safe Did Not Operate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417088 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061916, K071099. One submission often covers many models, so check the product and lot details in each record.
- Z-1098-2016 · Feb 10, 2016 · TerminatedIntra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
- Z-0428-2013 · Oct 19, 2012 · TerminatedIMRIS 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.
Other System, Nuclear Magnetic Resonance Imaging devices
- Ingenia Ingenia Elition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging14 recalls12 reports
- Ingenia Elition SPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging13 recalls2 reports
- NA Discovery MR750w 3.0TGE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging13 recalls0 reports
- Ingenia Ingenia Ambition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging12 recalls12 reports
- Ingenia Ingenia 3.0T CXPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls59 reports
- Ingenia Smartpath to dStream for 3.0TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls44 reports
- Ingenia Ingenia Elition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls5 reports
- MR 7000 Series MR 7700Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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