INFX-8000C Fluoroscopic X-Ray Systems
FDA Recall #Z-0843-2018 — Class II — December 29, 2017
Product Description
INFX-8000C Fluoroscopic X-Ray Systems
Reason for Recall
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
Recalling Firm
Toshiba American Medical Systems Inc — Tustin, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
19 units
Distribution
United States
Code Information
Serial Numbers: U6A1472001, UWB1422001, U6C13Y2007, A3A14Z2001, A6B1532003, A1B1552001, A6B1582004, A9B1622002, A9A1592001, A5C1622001, A6B1682005, A6B16X2006, A5C16Y2002, A1D1752002, AFA1662001, A9B1722003, A6B1742007, A6A1492002, A4B1472002
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated