Moderate riskFDA DeviceClass II

Philips Vue Motion V12 cardiac imaging software recalled for out-of-sequence image frames

Philips Vue Motion V12 cardiac imaging software (Product Number 1017979, software versions 12.2.0 through 12.2.8.500) may display image frames out of sequence during dynamic cine runs. This could cause medical staff to review cardiac images in the wrong order, potentially affecting diagnosis.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If your facility uses Philips Vue Motion V12, contact Philips Medical Systems for a software update or patch
  2. Review any recent patient studies processed with affected software versions for accuracy
  3. Check your system's software version against the list of affected versions (12.2.0–12.2.8.500)

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Vue Motion V12. Product Number: 1017979.
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
3,552 units
Illnesses reported
None reported
Manufactured in
Veenpluis 4-6, Best, Netherlands
Classification
Class II
Recall number
Z-1692-2026

In the FDA's words

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

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