Recall Z-1714-2014— Toshiba American Medical Systems Inc

Name: FDA recall Z-1714-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-12

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2014-05-12, terminated 2014-10-02. It names one FDA 510(k) clearance: K120073. Product: Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.. Reason: Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2014-05-12
Terminated: 2014-10-02
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120073 — INFX-8000V WITHToshibamedical Systems Corporation·cleared 2012-01-26

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

Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

Reason for recall

Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.

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