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Agfa N.V. recalls Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, gene
Recalled April 10, 2024 · FDA recall Z-1462-2024 · Agfa N.V
Hazard
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 · FDA Class II
Units
541 units
Sold at
Worldwide distribution - US Nationwide and the countries of 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, United Kingdom.
Description
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
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 and A5411/ 0400
Manufacturer(s)
Agfa N.V.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →