Agfa-Gevaert, N.V. recalls DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray im…

Recall date

December 4, 2018

Source

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

Recall number

Z-0692-2019

FDA classification

Class II

Brand / firm

Agfa-Gevaert, N.V.

Sold / distributed

US Nationwide Distribution in the states: IN, KS, MA, SC, and VA.

Why it was recalled

After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position.

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

What was recalled

DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.