Reported Apr 5, 2017 · Terminated

AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to…

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

Is this the product you have?

  • AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
Lot codes and dates
  • 307 of 307 codes

    • A5410000053
    • A5410000054
    • A5411000439
    • A5411000446
    • A5411000447
    • A5411000448
    • A5410000067
    • A5410000068
    • A5410000069
    • A5410000070
    • A5410000072
    • A5410000073
    • A5410000100
    • A5410000107
    • A5410000134
    • A5411000184
    • A5410000039
    • A5411000140
    • A5411000142
    • A5411000314
    • A5411000342
    • A5411000347
    • A5411000349
    • A5410000007
    • A5411000017
    • A5411000315
    • A5411000331
    • A5411000332
    • A5411000463
    • A5411000141
    • A5411000144
    • A5411000539
    • A5411000541
    • A5411000069
    • A5411000133
    • A5411000175
    • A5411000119
    • A5411000123
    • A5411000019
    • A5411000400
    • A5411000401
    • A5411000540
    • A5411000047
    • A5411000048
    • A5411000053
    • A5410000041
    • A5410000042
    • A5410000046
    • A5411000041
    • A5411000079
    • A5411000024
    • A5411000032
    • A5411000083
    • A5411000038
    • A5411000132
    • A5411000571
    • A5411000573
    • A5411000050
    • A5411000088
    • A5411000247
Amount recalled
308

Where it was sold

Why it was recalled

The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.

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 10, 2017 · Data as of Sep 19, 6:06 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.