RegWardenFDA facility compliance records
Company

Ziehm-Orthoscan INC.

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2024: 1 recalls120172018201920202021202220231202420252026
  • Recalls (2)

Registered facilities (1)

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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Ziehm-Orthoscan INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9073005-ziehm-orthoscan-inc/

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