Recall Z-0260-2018— Orthoscan, Inc.

Name: FDA recall Z-0260-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-31

Class II · Terminated

Class II FDA medical device recall by Orthoscan, Inc., initiated 2017-08-31, terminated 2021-04-21. It names one FDA 510(k) clearance: K113708. 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: 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.

Recalling firm: Orthoscan, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Terminated: 2021-04-21
Firm location: Scottsdale, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K113708 — ORTHOSCAN MOBILE DI MINI C-ARMOrthoscan, Inc.·cleared 2012-01-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.