Reported Jan 16, 2019 · Terminated

DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray…

Agfa-Gevaert, N.V.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Agfa-Gevaert, N.V. · Prins Boudewijnlaan · Kontich · N/A

Is this the product you have?

  • DX-D 600
  • DIRECT RADIOGRAPHY SYSTEM Product UsageThe 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 (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients
Lot codes and dates
  • Serial Numbers
    • A5430000015
    • A5430000020
    • A5430000030
    • A5430000042
    • A5430000052
    • A5430000061
    • A5430000066
    • A5430000067
    • A5430000079
    • A5430000081
Amount recalled
10

Where it was sold

Why it was recalled

After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 24, 2020 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.