Toshiba American Medical Systems Inc: Medical Device Recall in 2017 - (Recall #: Z-0012-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.

Product Classification:

Class II

Date Initiated: September 12, 2017

Date Posted: October 25, 2017

Recall Number: Z-0012-2018

Event ID: 78166

Reason for Recall:

During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.

Status: Terminated

Product Quantity: US - 96

Code Information:

Model: HDR-08A

Distribution Pattern:

USA (nationwide) Distribution

Voluntary or Mandated:

FDA Mandated