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
2UA15205XC2UA161JNHA5411002007A5411001003A54110010025CG51640402UA5481BVY5CG5171X81A5411002026A5411002025A54100000392UA62524PS2UA62524Q22UA62524RKA54110020312UA61218G45CG61266X62UA61218GG2UA63825HQ2UA642306H2UA4161JMY2UA52524Y52UA62524RJ2UA62524QV2UA62524QB2UA62524RJ2UA62524NS2UA62524PJ2UA62524Q9A5411000155A54110001512UA62524PH2UA62524QL2UA62524QTA54110001532UA62524Q05CG6126B9J5CG61266YW5CG61266VP5CG61268BG5CG612673N2UA6243GNY2UA62424R82UA62524P42UA62524RY2UA6243GPT2UA62524Q62UA62524PRA54110001522UA63825HR2UA31000Q62UA31000Q82UA31000R52UA31000QR2UA319120W2UA31912112UA31000PS2UA31000QX2UA31000Q02UA31000PX
- 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.
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