Agfa Healthcare NX 3.0.8950 Imaging Processing Software
FDA Device Recall #Z-2735-2017 - Class II, December 21, 2016
Recall Summary
| Recall Number | Z-2735-2017 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 21, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AGFA Healthcare Corp. |
| Location | Greenville, SC |
| Product Type | Devices |
| Quantity | 221 units |
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.
Distribution Pattern
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
Lot / Code Information
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
Other Recalls from AGFA Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0923-2026 | Class II | Brand name: AGFA Digital Radiography X- Ray sys... | Nov 18, 2025 |
| Z-2652-2017 | Class II | IMPAX Cardiovascular The IMPAX CV Reporting mo... | Dec 22, 2016 |
| Z-1738-2017 | Class II | DX-D600 - DXD Imaging Package | May 2, 2016 |
| Z-1698-2017 | Class II | AGFA Digital Radiography X-Ray System DX-D100 ... | Jan 20, 2016 |
| Z-0283-2016 | Class II | IMPAX, PACS, Picture Archive and Communications... | Sep 1, 2015 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.