Agfa N.V. recalls DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospi…

Recall date

August 15, 2018

Source

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

Recall number

Z-3245-2018

FDA classification

Class II

Brand / firm

Agfa N.V.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada.

Why it was recalled

A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.

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 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.