Agency classClass IOur severity:Critical FDA (Devices)·Z-0161-2026·Announced 2025-11-05

Neuro operating suites recalled over ice blockage in magnet venting paths

IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.

Plain-English summary

The IMRIS Operating Suite, Neuro III-SV iMRI System and iMRX System, containing a Siemens 3 Tesla MRI magnet (Verio), is being recalled across part numbers including 105118-000 and 105118-001. The record notes these part numbers predate UDI and carry no UDI/DI.

Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture that system and potentially result in a helium leak into the scanning room.

The product was distributed worldwide, including nationwide in the United States and to Canada, Sweden, Switzerland, Japan, Australia, Qatar and China. The FDA has classified the recall as Class I, its most serious category, used where there is a reasonable probability of serious injury or death.

Sites operating an affected suite should follow the firm's instructions.

The recalled product

Product: IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Manufacturer: IMPRIS Imaging Inc
Category: Medical Device — MRI system
Hazard: helium-release
quench
pressure-rupture
class-i
ice-blockage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

IMRIS Part Number(s): 105118-000
UDI/DI None predates UDI
105118-001
105117-003
105117-004
105048-000
105048-001
105103-001
105071-004
105824-000
UDI/DI 00857534006189
105828-000
UDI/DI 00857534006165
116189-000
UDI/DI 00857534006202
118396-000
UDI/DI 00857534006196.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by IMPRIS Imaging Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · IMPRIS Imaging Inc

See all →

Critical
MRI operating suites recalled over ice blockage in the magnet venting system
FDA (Devices) · 2025-11-05
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FDA (Devices) · 2025-11-05
Critical
InVision operating suite recalled over ice blockage in magnet venting paths
FDA (Devices) · 2025-11-05

Same hazard · helium release