Facility

INSIGHT MEDICAL SYSTEMS, INC

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

Key facts

3recalls · worst Class II

—inspections in our data

—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)	3019878658
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	9801 Metric Boulevard Austin, TX, US 78758
Registration status	Active · expires 2026
Parent company	Kico Knee Innovation Company (owner-operator 10054916)
Brand names	ARVIS® Shoulder; ARVIS Surgical Navigation System

Activity by year

Recalls (3)

Devices registered here (3)

Orthopedic Augmented Reality
Product code SBF (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560
Automated Radiological Image Processing Software
Product code QIH (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050
System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IIOngoing2026-07-13
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Class IIOngoing2026-04-23
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Class IIOngoing2025-09-19
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

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. “INSIGHT MEDICAL SYSTEMS, INC (FEI 3019878658) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3019878658-insight-medical-systems-inc/

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