Z-0843-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- December 29, 2017
- Termination Date
- November 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
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.
Distribution Pattern
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