IMRIS Imaging, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000041458 FEI 3010326005
IMRIS Imaging, Inc. is a medical device manufacturer based in the United States, with 94 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I) and 7 FDA recalls as of 14 Nov 2026.
- Devices
- 94
- Registrations
- EUDAMEDFDA
- FDA recalls
- 77 ongoing
Registry facts
- Registries
- FDA GUDID 93
- EUDAMED 1
- FDA 510(k) 1
- Device classes
- FDA Class II 59
- FDA Class I 34
- EU Class I 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000041458
- FDA FEI 3010326005
- DUNS 079990922
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
What IMRIS Imaging, Inc. makes
IMRIS Imaging, Inc. manufactures full-body MRI systems with superconducting magnets, MRI radio-frequency coils, and basic diagnostic powered x-ray system tables. They also produce operating room audiovisual data and device management systems (both application software and hardware), skull clamps, reusable freestanding headrests, and stationary digital angiographic x-ray systems.
The company's devices are classified as Class I and Class II medical devices and are listed in the EUDAMED, FDA 510(k), and FDA UDI registries. IMRIS Imaging, Inc. is based in the United States.
Catalogue
Search and filter all 94 devicesShowing 1-50 of 94
Company details
- EUDAMED SRN
- US-MF-000041458
- FDA FEI number
- 3010326005
- DUNS number
- 079990922
- EU VAT number
- DE270849261
- EUDAMED status
- Active
- EUDAMED registered name
- IMRIS Imaging, Inc.
- Registered address
- 1230, Chaska Creek Way, 55318, Chaska, United States
- Website
- www.imris.com
- sshah@imris.com
- PRRC contact
- Sanjay Shah
FDA recalls
FDA recall records list 3 recalls initiated by IMRIS Imaging, Inc., the earliest on 2025-12-08 and the most recent on 2026-08-06. By recorded status: 3 ongoing. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 5
- 2026 2
2026
- 6 Aug 2026 Z-3033-2026 Class II Ongoing The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
- 6 Aug 2026 Z-3034-2026 Class II Ongoing The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
2025
- 8 Dec 2025 Z-1034-2026 Class II Ongoing Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
Full distribution text
- 30 Sep 2025 Z-0161-2026 Class I Ongoing There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. 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 the helium containment system, potentially resulting in a helium leak into the scanning room.
Full distribution text
- 30 Sep 2025 Z-0162-2026 Class I Ongoing There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. 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 the helium containment system, potentially resulting in a helium leak into the scanning room.
Full distribution text
- 30 Sep 2025 Z-0163-2026 Class I Ongoing There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. 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 the helium containment system, potentially resulting in a helium leak into the scanning room.
Full distribution text
- 30 Sep 2025 Z-0164-2026 Class I Ongoing There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. 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 the helium containment system, potentially resulting in a helium leak into the scanning room.
Full distribution text
- 8 Dec 2025 Z-1034-2026 Class II Ongoing Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
Frequently asked questions
How many devices does IMRIS Imaging, Inc. have in the registry?
The registry currently lists 94 devices for IMRIS Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list IMRIS Imaging, Inc.'s devices?
Among its 50 most recently registered devices, IMRIS Imaging, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do IMRIS Imaging, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for IMRIS Imaging, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for IMRIS Imaging, Inc.?
FDA recall records list 7 recalls initiated by IMRIS Imaging, Inc., the most recent initiated on 6 Aug 2026. 7 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from IMRIS Imaging, Inc. in the registry?
The most recently registered devices listed for IMRIS Imaging, Inc. include VISIUSmatrix 120906-000, IMRISeye P122506, Horseshoe Headrest 116098-000 and Neuro II-SE 105000-00X.