Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DX-D 600 Product Usage: The DX-D 600 system is a Recalled by Agfa N.V. Due to A supplier for the Agfa system noted a...

Date: August 15, 2018
Company: Agfa N.V.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Agfa N.V. directly.

Affected Products

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.

Quantity: 108

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Agfa N.V.

Agfa N.V. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report