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
FDA Recall Z-1462-2024 · Posted 2024-04-02
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Recalling FirmAgfa N.V.
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2024-02-23
Product Quantity541 units
Reason for Recall
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
Firm Action
AGFA issued Urgent Field Safety Notice via email on 2/23/24. Letter states reason for recall, heallh risk and action to take:
Agfa/local business partner will inspect the cable of your device at the earliest opportunity and will replace it in case of any potential malfunction of the safety system.
If you have any questions about this matter, please contact your local Agfa NV organization/local business partner.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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