Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1462-2024 — 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

U.S. FDA — Device Enforcement · Belgium · 2024-02-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1462-2024
Date of alert: 2024-02-23
Country / jurisdiction: Belgium
Risk level: Class II
Risk type: recall
Brand: Agfa N.V.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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