Agency classClass IIOur severity:High FDA (Devices)·Z-1462-2024·Announced 2024-04-10

Mobile X-ray System Structural Cable Defect Affects Safety Function

Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a structural safety defect in medical equipment. The recall fits the 'risk-of-harm product where injury has not yet been reported' criterion. No hospitalizations or injuries have been reported, but the cable defect creates potential for patient harm.

Plain-English summary

The Agfa DX-D 100 system is a mobile digital radiography X-ray system used in clinical settings to generate projection X-ray images of patients. The system consists of an X-ray console, generator, tube, digital detector, and workstation, with a mobile column supporting a telescopic arm that holds the tube head.

The recall addresses a structural defect in the steel cable installed inside the mobile column. This cable is responsible for supporting the weight of the telescopic arm and tube head. An interference in the cable assembly could prevent the safety system from functioning properly. This safety system is designed to block or secure the arm if the cable becomes cut or severed, preventing the arm and tube head from falling.

The risk is that if the cable fails and the safety mechanism does not activate due to the interference, the telescopic arm could move or fall unexpectedly, potentially resulting in patient injury. The defect affects 541 units distributed worldwide, including throughout the United States and in Canada, Argentina, Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, and the United Kingdom.

Customers who own or operate affected Agfa DX-D 100 systems should contact Agfa N.V. for information about the defect and available remediation options.

The recalled product

Product: 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…
Manufacturer: Agfa N.V.
Category: Medical Device — X-ray Equipment
Hazard: structural-defect
safety-mechanism-failure
Affected units: 541

Distribution

Distributed nationwide across the United States.

Same manufacturer · Agfa N.V.

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Same hazard · structural defect