Reported Jun 12, 2013 · Terminated

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality…

AGFA Corp.

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 Corp. · 10 S Academy St · Greenville, SC · 29601-2632

Is this the product you have?

  • AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull
  • spinal column and extremitieschest, abdomen, and other body parts
Lot codes and dates
  • Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U
Amount recalled
104

Where it was sold

Why it was recalled

Customers could potentially experience intermittent, unintended and illogical movement when using the product.

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 Dec 31, 2014 · Data as of Sep 19, 5:33 PM UTC

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