Reported Jul 26, 2017 · Terminated

Agfa Healthcare NX 3.0.8950 Imaging Processing Software

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 Healthcare NX 3.0.8950 Imaging Processing Software
Lot codes and dates
  • 220 of 220 codes

    • 2UA15205XC
    • 2UA161JNH
    • A5411002007
    • A5411001003
    • A5411001002
    • 5CG5164040
    • 2UA5481BVY
    • 5CG5171X81
    • A5411002026
    • A5411002025
    • A5410000039
    • 2UA62524PS
    • 2UA62524Q2
    • 2UA62524RK
    • A5411002031
    • 2UA61218G4
    • 5CG61266X6
    • 2UA61218GG
    • 2UA63825HQ
    • 2UA642306H
    • 2UA4161JMY
    • 2UA52524Y5
    • 2UA62524RJ
    • 2UA62524QV
    • 2UA62524QB
    • 2UA62524RJ
    • 2UA62524NS
    • 2UA62524PJ
    • 2UA62524Q9
    • A5411000155
    • A5411000151
    • 2UA62524PH
    • 2UA62524QL
    • 2UA62524QT
    • A5411000153
    • 2UA62524Q0
    • 5CG6126B9J
    • 5CG61266YW
    • 5CG61266VP
    • 5CG61268BG
    • 5CG612673N
    • 2UA6243GNY
    • 2UA62424R8
    • 2UA62524P4
    • 2UA62524RY
    • 2UA6243GPT
    • 2UA62524Q6
    • 2UA62524PR
    • A5411000152
    • 2UA63825HR
    • 2UA31000Q6
    • 2UA31000Q8
    • 2UA31000R5
    • 2UA31000QR
    • 2UA319120W
    • 2UA3191211
    • 2UA31000PS
    • 2UA31000QX
    • 2UA31000Q0
    • 2UA31000PX
Amount recalled
221 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new AGFA Healthcare Corp. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 10, 2019 · 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.