FDADecember 21, 2016device

Agfa Healthcare NX 3.0.8950 Imaging Processing Software

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

The hazard

A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.

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 Healthcare NX 3.0.8950 Imaging Processing Software — Recall Details · AllClear