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FDAJanuary 20, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

agfa healthcareagfa

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear