Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mobile Mini C-arm system Part # 1000-0001. Intended to provide Recalled by Orthoscan, Inc. Due to OrthoScan Inc. discovered during investigation of a non-standard...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Orthoscan, Inc. directly.
Affected Products
Mobile Mini C-arm system Part # 1000-0001. 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.
Quantity: 2012 total
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Orthoscan, Inc.
Orthoscan, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report