Toshiba American Medical Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-0844-2018)

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-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

Product Classification:

Class II

Date Initiated: December 29, 2017

Date Posted: March 14, 2018

Recall Number: Z-0844-2018

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: 29 units

Code Information:

Serial Numbers: UFD13X2015, UFD13X2016, UUC13Z2011, UEC1422013, UFD1442017, UFD1452018, AAA1642005, UUC1452012, UTC14Y2008, ACA1472001, ACA1492002, AAA1492001, AAA14X2002, A8A1532001, A9A1542001, AAA1542003, A9A1582002, ABB1627001, ACB1622003, A9A1662003, AAA1692006, A9A16X2004, A8B16Y2002, A7B16Y2001, ACB16Y2004, AAA1632004, AAA1712007, W4B1622031, W4B14Y2023

Distribution Pattern:

United States

Voluntary or Mandated:

Voluntary: Firm initiated