FDA-Device2026-04-08Class II

Vue Motion V12. Product Number: 1017979.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Hazard

Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

Sold states

Worldwide distribution - US Nationwide and the countries of Algeria, Andorra, Angola, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Guernsey, Holy See (Vatican City State), Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Zambia.

Affected count

3,552 units

Manufactured in

Veenpluis 4-6, Best, Netherlands

Products

Vue Motion V12. Product Number: 1017979.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2026

Original summary

Vue Motion V12. Product Number: 1017979. Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. Product Number: 1017979, Software Version: v12.2.0 - v12.2.8.500. UDI Numbers: (01)00884838100367(11)200221(10)12.2.5, (01)00884838100367(11)230223(10)12.2.8.300, (01)00884838100343(11)200423(10)12.2.5.0, (01)00884838100367(11)230615(10)12.2.8.310, (01)00884838100367(11)200903(10)12.2.5.1, (01)00884838100367(11)230720(10)12.2.8.400, (01)00884838100343(11)201125(10)12.2.5.100, (01)00884838100367(11)230921(10)12.2.8.410, (01)00884838100343(11)210217(10)12.2.5.200, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)210628(10)12.2.5.300, (01)00884838100350(11)240116(10)12.2.8.421, (01)00884838100367(11)210628(10)12.2.5.300, (01)00884838100350(11)240204(10)12.2.8.422, (01)00884838100343(11)220525(10)12.2.5.400, (01)00884838100350(11)240226(10)12.2.8.424, (01)00884838100367(11)230223(10)12.2.5.405, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100336(11)230301(10)12.2.5.406, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)230320(10)12.2.5.407, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)230403(10)12.2.5.408, (01)00884838100367#(11)231223(10)12.2.8.435, (01)00884838100343(11)240211(10)12.2.5.413,(01)00884838100367#(11)231228(10)12.2.8.435A, (01)00884838100343(11)20240923(10)12.2.5.414, (01)00884838100343(11)240917(10)12.2.8.436, (01)00884838100343(11)250728(10)12.2.5.416, (01)00884838100367(11)241014(10)12.2.8.437, (01)00884838100367(11)210308(10)12.2.8.0, (01)00884838100343(11)241128(10)12.2.8.438, (01)00884838100367(11)220127(10)12.2.8.100, (01)00884838100367(11)250122(10)12.2.8.439, (01)00884838100343(11)220417(10)12.2.8.130, (01)00884838100350(11)240407(10)12.2.8.440, (01)00884838100350(11)221213(10)12.2.8.200, (01)00884838100367(11)210308(10)12.2.8.0, (01)00884838100350(11)230301(10)12.2.8.210, (01)00884838100367(11)240616(10)12.2.8.500. Equipment Number: 86183662, 118470289, 115532146, 115483951, 117699552, 86093591, 98297412, 86093647, 86241626, 86093616, 119288183, 86241420, 86326303, 86325905, 86325795, 86325794, 86325747, 86325221, 86093571, 108816071, 86093582, 86093358, 86093539, 86241707, 86241692, 86093595, 86241861, 86241751, 86241678, 86324616, 116468394, 106682968, 86241742, 87750382, 108664430, 118757545, 87751135, 87750882, 86325445, 86241699, 86241684, 86241669, 86241750, 86093376, 89412152, 86093502, 86369383, 86093605, 120505331, 86093623, 86093339, 86093663, 86093678, 86367969, 104418433, 86325612, 86093588, 86093356, 86324563, 86093674, 86093646, 86093566, 86093685, 86093659, 118007768, 107808460, 119061786, 86093547, 88168079, 86326302, 86325187, 86325123, 86093545, 86093435, 86093427, 95752135, 94477265, 92029774, 92029787, 87771660, 117645555, 117645550, 86241704, 86241689, 86241674, 107639091, 112190786, 112190691, 86093283, 106771488, 110432369, 110432367, 106771482, 119091432, 119091431, 118487430, 118487429, 97582725, 97582724, 97582723, 97582653, 97582719, 97582717, 97582716, 87940696, 107632484, 116468405, 106410735, 117979657, 86241787, 86241771, 107327494, 107327505, 118832692, 99601715, 99601713, 94677044, 92107086, 118239830, 117908479, 97223395, 96789905, 116645253, 116645227, 99601477, 99601462, 101939624, 101939623, 108423189, 108423187, 112368329, 94774385, 118905692, 115619712, 108420051, 86097812, 117795737, 95364241, 86097897, 119690483, 119690374, 119690229, 119690557, 108374575, 86097930, 86097807, 86367896, 94645462, 94645430, 94645536, 94644301, 94644110, 95364465, 86097900, 86097899, 86097870, 86097869, 86097867, 86097866, 86097865, 86097864, 86097872, 86097797, 93942911, 86097968, 95864471, 95863241, 95862554, 95861090, 95857876, 95857299, 95857238, 95856111, 116036959, 108387852, 108387818, 108387787, 108385798, 108385775, 108385742, 86097888, 92994681, 92994630, 92994624, 92994574, 92994546, 92994507, 92994368, 92993154, 92993151, 92993146, 92992839, 92992837, 92994642, 92993515, 86097956, 86097802, 86097795, 86097958, 86097957, 86097885, 86097884, 86097912, 86097911, 86097910, 86097874, 99156870, 86242184, 95635728, 86142456, 86539251, 98748118, 98746992, 100367081, 96233639, 100638306, 112044793, 112045596, 112045794, 117541969, 114535249, 98747092, 95635888, 97933599, 94881635, 86168167, 100428338, 98489592, 98489557, 106973031, 93903547, 100159454, 102820056, 102802637, 113204610, 95805302, 95805287, 95805271, 95805255, 95805242, 95805217, 94881654, 94881640, 98346586, 98346584, 98346582, 94799727, 98238281, 98238276, 98238267, 98238261, 98238253, 98238243, 98238237, 98238230, 98238226, 98238221, 98237322, 98237318, 116646058, 116646033, 116646026, 116645649, 116645624, 117182354, 116646037, 118828892, 118828856, 117097056, 117096664, 117096497, 117096075, 117095988, 117095970, 117094564, 117094474, 117094452, 117094420, 118828939, 118828867, 93042188, 93041325, 86095135, 86095074, 86095099, 104840334, 98948136, 105562169, 86094

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