Agfa Healthcare NX 3.0.8950 Imaging Processing Software
This recall has been terminated (originally issued December 21, 2016).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- December 21, 2016
- Terminated
- July 10, 2019
- Recall Number
- Z-2735-2017
- Quantity
- 221 units
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
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
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 Info
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
Root Cause
Device Design
Action Taken
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.