Class II — Potential Health Hazard

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

Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile Recalled by Agfa N.V. Due to Steel cable installed inside the mobile column which...

Date: February 23, 2024
Company: Agfa N.V.
Status: Ongoing
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

Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

Quantity: 541 units

Why Was This Recalled?

Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury

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