Facility

IMRIS Imaging, Inc.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010326005
Establishment type	Manufacture Medical Device
Location	1230 Chaska Creek Way Suite 100 Chaska, MN, US 55318
Registration status	Active · expires 2026
Parent company	IMRIS Imaging, Inc. (owner-operator 10050332)
Brand names	ORT 400 (TruSystem 7500 MR) Table and Accessories

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Table, Operating-Room, Electrical
Product code GDC (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4960

Recalls & enforcement

Class IIOngoing2026-08-06
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 procedur…
Class IIOngoing2025-12-08
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.

FDA inspections (2)

VAI2019-10-01
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2018-01-26
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by IMRIS Imaging, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “IMRIS Imaging, Inc. (FEI 3010326005) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010326005-imris-imaging-inc/

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