INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Recall #Z-0844-2018 — Class II — December 29, 2017
Product Description
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
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
29 units
Distribution
United States
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated