Recall Z-2735-2017— AGFA Healthcare Corp.

Name: FDA recall Z-2735-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Class II · Terminated

Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2016-12-21, terminated 2019-07-10. It names one FDA 510(k) clearance: K090672. Product: Agfa Healthcare NX 3.0.8950 Imaging Processing Software. Reason: 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..

Recalling firm: AGFA Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-12-21
Terminated: 2019-07-10
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K090672 — AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONSAgfa Healthcare N.V.·cleared 2009-05-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Agfa Healthcare NX 3.0.8950 Imaging Processing Software

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.