Infx-8000F (Infinix Csi and Infinix Dpi)

• • Ongoing Z-1176-2021 FDA Class II ·initiated 5 Feb 2021

  The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

• • Ongoing Z-1271-2021 FDA Class II ·initiated 8 Dec 2020

  System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

• • Ongoing Z-2327-2020 FDA Class II ·initiated 3 Mar 2020

  Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

• • Terminated Z-0360-2020 FDA Class II ·initiated 8 Feb 2019

  Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.

• • Terminated Z-0842-2018 FDA Class II ·initiated 29 Dec 2017 ·on shared 510(k) K081624

  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.

• • Terminated Z-0994-2013 FDA Class II ·initiated 8 Nov 2012

  Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.

• • Terminated Z-0331-2012 FDA Unclassified (pre-2012) ·initiated 3 Oct 2011

  The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being tranferred may fall from the tabletop.

• • Terminated Z-0005-2009 FDA Unclassified (pre-2012) ·initiated 29 Sep 2008

  Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K081624 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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