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

Recalled October 25, 2017 · FDA recall Z-0012-2018 · Toshiba American Medical Systems

Hazard

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. · FDA Class II

Units

US - 96

Sold at

USA (nationwide) Distribution

Description

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.

Product

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.

Manufacturer(s)

Toshiba American Medical Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →