FDAAugust 15, 2018device

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, spi...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

agfa n vagfa

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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