Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0258-2018 — 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.

U.S. FDA — Device Enforcement · United States · 2017-08-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0258-2018
Date of alert: 2017-08-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Orthoscan, Inc.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0258-2018 — 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.

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