Z-2735-2017Class II

Agfa Healthcare NX 3.0.8950 Imaging Processing Software

Name: Z-2735-2017 Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Creator: AGFA Healthcare Corp.
Published: 2016-12-21
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2016-12-21 / Terminated / root cause: design

FDA source

AGFA Healthcare Corp. began a recall of Agfa Healthcare NX 3.0.8950 Imaging Processing Software on 2016-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2735-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-21
Posted: 2017-07-14
Terminated: 2019-07-10
Recalling firm: AGFA Healthcare Corp.
Product: Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: design
FDA root cause: Device Design
Action: On December 22, 2016, an URGENT FIELD SAFETY NOTICE letter was sent either by mail or email. The letter included an acknowledgement form to be returned. The letter informed the customer of the problem and actions to be taken.
Quantity in commerce: 221 units
Distribution: AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada
Product codes and lots: 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, A5411000346, A5411000232, A541000199, A5411000210, A5411000209, 2UA62524P8, 5CG61266R5, 5CG5295760, 5CG5285W67, 5C5285W7P, 5CG5285W9Y, 5CG5285W5R, 5CG528W7B, A5411001163, A5411000468, 2UA52524XM, 2UA5481BTP, A5411000145, 2UA25009HM, A5411001064, A5411000159, 2UA3380VMW, 2UA3380VMG, 2UA3461QSD, A5411001039, A5411001066, A5411001065, A5411000230, A5411000177, A5411000174, CZC6349KSZ, 2UA62524RH, 2UA62524R4, 2UA6254Q7, A5411000116, A5411002095, A5411002093, A5411002092, A5411001173, A5411001172, 2UA6243GPK, 2UA6243GPL, 2UA62524QH, 2UA4150QFZ, 2UA4150QFQ, 2UA1110ZYG, 2UA3021KYP, 2UA52524XC, 2UA52524YK, 2UA52524YQ, A5411001105, MXL24220J8, A5411002030, A5411001089, A5411002058, 2UA2181HSV, A5411000238, 2UA6021JXG, 2UA511BZ2, A5411000341, A5411000340, A5411000337, 2UA5111C0V, CZ6357GKR, CZC6357GFM, A5411002051, A5411002048, A5411002047, A5411002052, A5411002049, A5411000549, 2UA62524RW, 2UA62524QS, 2UA62524P7, 2UA62524R7, 2UA62524QM, A5410001000, A5410000132, 2UA5170ZKM, 2UA5422QN4, 2UA62524PP, 2UA62524R6, 2UA1221B32, 2UA62524QD, A5411002033, 2UA62524RX, 5CG6126743, 2UA62524PB, 2UA44616DJ, 2UA63825J3, 2UA62524P6, 2UA62524QF, 2UA62524PL, 5CG61266QW, 2UA62524PN, 2UA62524RS, 2UA62524RQ, 2UA62524QJ, 5C61266Y4, A5411002064, A54110002059, CZC6349KXK, 2UA5111BZC, 2UA642306K, 2UA63825J4, 2UA64029N9, 2UA62524PD, 2UA62524P1, 2UA62524Q8, 2UA63825J6, 2UA63825JD, 2UA62524P0, 2UA63825HS, 2UA63825HN, 2UA63825J5, 2UA63825J8, 2UA61225X9, 2UA62524PT, 2UA63825J0, 2UA62524PV, 2UA5111BYZ, 5CG61266YZ, 2UA62524NY, 2UA62524RV, 5CG61266MG, 2UA63825JC, 2UA63825HX, 2UA62524QZ, 2UA62524QR, 2UA62524PF, 5CG53032V5, 2UA52223Q2, 2UA52223Q4, 2UA51519JR, 2UA62524RP, 2UA32878M, 2UA5451JKP, 2UA62524RG, 2UA62524R5, 2UA62524RN, 2UA63825HM, A5411002022, A45411000018, A5411002057, 2UA63825HZ, A5411000180, 2UA15205X9, 2UA62524NX, 2UA31000Q9, A5411000179, 2UA5451JL2, 2UA1510H6B, 2UA5311CS3, 2UA61218GT, CZC6057ZSL, A5411002024, 2UA62524RM, 2UA62524PY, 2UA1510H60, 2UA1510H5C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2735-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2735-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-14

Product code MQB

K090672Class IIAgfa Computed Radiography Systems with Nx WorkstationsAgfa Healthcare N.V. / cleared 2009-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)