Recall Z-0843-2018— Toshiba American Medical Systems Inc

Name: FDA recall Z-0843-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-29

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2017-12-29, terminated 2023-11-29. It names one FDA 510(k) clearance: K152697. Product: INFX-8000C Fluoroscopic X-Ray Systems. Reason: 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
Classification: Class II
Status: Terminated
Initiated: 2017-12-29
Terminated: 2023-11-29
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K152697 — INFX-8000C, V6.20Toshibamedical Systems Corporation·cleared 2016-01-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.