Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2735-2017 — Agfa Healthcare NX 3.0.8950 Imaging Processing Software

U.S. FDA — Device Enforcement · United States · 2016-12-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2735-2017
Date of alert
2016-12-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
AGFA Healthcare Corp.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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