Virtual Imaging, Inc. recalls RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic…

Recall date

November 2, 2018

Source

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

Recall number

Z-0460-2019

FDA classification

Class II

Brand / firm

Virtual Imaging, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of, Canada, Italy

Why it was recalled

There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.

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

What was recalled

RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography