Recall Z-1462-2024 ยท IZL System, X-Ray, Mobile
Agfa N.V.
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
| Date | Apr 2, 2024 (initiated Feb 23, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Component design/selection |
| 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. |
| Quantity | 541 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103597 | DX-D 100 Agfa Healthcare N.V., Jan 3, 2011 |