Facility

ORTHOSCAN, INC.

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

Key facts

2recalls · worst Class II

1inspections · worst NAI

—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)	3005254598
Establishment type	Manufacture Medical Device
Location	14555 N. 82nd Street SCOTTSDALE, AZ, US 85260
Registration status	Active · expires 2026
Parent company	Ziehm-Orthoscan INC. (owner-operator 9073005)
Brand names	Orthoscan TAU Mini C-arm

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

Solid State X-Ray Imager (Flat Panel/Digital Imager)
Product code MQB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680
Image-Intensified Fluoroscopic X-Ray System, Mobile
Product code OXO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
System, X-Ray, Fluoroscopic, Image-Intensified
Product code JAA (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650

Recalls & enforcement

Class IIOngoing2024-08-08
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such a…
Class IITerminated2017-08-31
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed b…

FDA inspections (1)

NAI2018-11-20
No Action Indicated · Compliance: Devices

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 Ziehm-Orthoscan 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. “ORTHOSCAN, INC. (FEI 3005254598) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005254598-orthoscan-inc/

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