Agfa DX-D 600 X-Ray System Recalled for Potential Cable Failure

Plain-English summary

Agfa N.V. is recalling 108 units of the DX-D 600 General Radiography X-Ray imaging system. The recall was initiated after a supplier noted a potential for the steel support cables of a similar device to break. This finding led to a mandatory review of all systems to check for cable deterioration or irregular pulley wear.

The DX-D 600 is a ceiling-mounted system used in hospitals, clinics, and medical practices to create static X-ray images of the skeleton, chest, and abdomen. The affected units were distributed nationwide in the United States and to Canada. 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.

Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. The recall involves changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear is found during the review.

The recalled product

Product

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

Manufacturer

Agfa N.V.

Category

Medical Device — Radiography Equipment

Hazard

• falling-object
• structural-failure

Affected units

108

Distribution

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