Toshiba American Medical Systems Inc recalls Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic im…

Recall date

September 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0012-2018

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

USA (nationwide) Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.