# FDA recall Z-0260-2018

> **Orthoscan, Inc.** · Class II · device recall initiated 2017-08-31.

## Product

Mobile Mini C-arm system Part # 1000-0005.     Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

## Reason for recall

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 by the user

## Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.

## Key facts

- **Recall number:** Z-0260-2018
- **Recalling firm:** Orthoscan, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-31
- **Report date:** 2018-01-17
- **Termination date:** 2021-04-21

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Scottsdale, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2018

## Citation

> AI Analytics. FDA recall Z-0260-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0260-2018. Source: US FDA. Licensed CC0.

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