Toshiba American Medical Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-0843-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

INFX-8000C Fluoroscopic X-Ray Systems

Product Classification:

Class II

Date Initiated: December 29, 2017

Date Posted: March 14, 2018

Recall Number: Z-0843-2018

Event ID: 79153

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.

Status: Terminated

Product Quantity: 19 units

Code Information:

Serial Numbers: U6A1472001, UWB1422001, U6C13Y2007, A3A14Z2001, A6B1532003, A1B1552001, A6B1582004, A9B1622002, A9A1592001, A5C1622001, A6B1682005, A6B16X2006, A5C16Y2002, A1D1752002, AFA1662001, A9B1722003, A6B1742007, A6A1492002, A4B1472002

Distribution Pattern:

United States

Voluntary or Mandated:

Voluntary: Firm initiated