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Recall Observatory FDA recall evidence

Device product

IVEA Product Part Number 16100 Model 500A

Z-3239-2017

August 24, 2017

Class II

Product summary

Firm
Firefly Medical, Inc.
Event
Event 78019
Status
Terminated
Classification
Class II
Quantity
570 units
Official record key
device-enforcement:Z-3239-2017

Official wording

Reason: The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.

Code information: Serial Numbers - 100201, 100251, 100297, 100343, 100390, 100438, 100487, 100666, 100586, 100202, 100252, 100298, 100344, 100391, 100439, 100488, 100667, 100587, 100204, 100253, 100299, 100345, 100392, 100440, 100489, 100507, 100588, 100205, 100254, 100300, 100346, 100393, 100441, 100490, 100508, 100592, 100206, 100255, 100301, 100347, 100394, 100442, 100491, 100509, 100593, 100207, 100256, 100302, 100348, 100395, 100443, 100492, 100510, 100594, 100208, 100257, 100303, 100349, 100396, 100444, 100493, 100511, 100597, 100209, 100258, 100304, 100350, 100397, 100445, 100615, 100512, 100598, 100210, 100259, 100305, 100351, 100398, 100446, 100616, 100513, 100599, 100211, 100260, 100306, 100352, 100399, 100447, 100617, 100515, 100600, 100212, 100261, 100307, 100353, 100401, 100448, 100618, 100516, 100601, 100213, 100262, 100308, 100354, 100402, 100449, 100620, 100520, 100602, 100214, 100263, 100309, 100356, 100403, 100450, 100623, 100522, 100605, 100215, 100264, 100310, 100357, 100404, 100451, 100624, 100524, 100606, 100216, 100265, 100311, 100358, 100405, 100452, 100625, 100525, 100674, 100217, 100266, 100312, 100359, 100406, 100453, 100626, 100528, 100675, 100218, 100267, 100313, 100360, 100407, 100454, 100627, 100530, 100676, 100219, 100268, 100314, 100361, 100408, 100455, 100636, 100532, 100677, 100221, 100269, 100315, 100362, 100409, 100456, 100640, 100534, 100678, 100222, 100270, 100316, 100363, 100410, 100457, 100641, 100538, 100679, 100223, 100271, 100317, 100364, 100411, 100458, 100642, 100544, 100680, 100224, 100272, 100318, 100365, 100412, 100459, 100643, 100545, 100495, 100225, 100273, 100319, 100366, 100413, 100460, 100644, 100546, 100497, 100226, 100274, 100320, 100367, 100414, 100461, 100645, 100547, 100498, 100227, 100275, 100321, 100368, 100415, 100462, 100646, 100548, 100499, 100228, 100276, 100322, 100369, 100416, 100463, 100647, 100549, 100500, 100230, 100277, 100323, 100370, 100417, 100464, 100648, 100550, 100501, 100231, 100278, 100324, 100371, 100418, 100465, 100649, 100551, 100502, 100232, 100279, 100325, 100372, 100419, 100466, 100650, 100552, 100503, 100233, 100280, 100326, 100373, 100420, 100467, 100651, 100553, 100504, 100234, 100281, 100327, 100374, 100421, 100468, 100652, 100554, 100514, 100235, 100282, 100328, 100375, 100422, 100469, 100653, 100556 100519, 100236, 100283, 100329, 100376, 100423, 100472, 100654, 100558, 100521, 100237, 100284, 100330, 100377, 100424, 100474, 100655, 100562, 100523, 100238, 100285, 100331, 100378, 100425, 100475, 100656, 100564, 100526, 100239, 100286, 100332, 100379, 100426, 100476, 100657, 100565, 100527, 100240, 100287, 100333, 100380, 100428, 100477, 100658, 100569, 100529, 100241, 100288, 100334, 100381, 100429, 100478, 100659, 100570, 100531, 100242, 100289, 100335, 100382, 100430, 100479, 100660, 100571, 100533, 100243, 100290, 100336, 100383, 100431, 100480, 100661, 100572, 100535, 100244, 100291, 100337, 100384, 100432, 100481, 100779, 100574, 100536, 100245, 100292, 100338, 100385, 100433, 100482, 100473, 100576, 100537, 100246, 100293, 100339, 100386, 100434, 100483, 100662, 100579, 100539, 100247, 100294, 100340, 100387, 100435, 100484, 100663, 100581, 100540, 100249, 100295, 100341, 100388, 100436, 100485, 100664, 100583, 100541, 100250, 100296, 100342, 100389, 100437, 100486, 100665, 100584, 100542, 100555, 100689, 100736, 100784, 100831, 100878, 100926, 100973, 101021, 100557, 100690, 100737, 100785, 100832, 100879, 100927, 100974, 101022, 100559, 100691, 100738, 100786, 100833, 100880, 100928, 100975, 101023, 100560, 100692, 100739, 100787, 100834, 100881, 100929, 100976, 101024, 100561, 100693, 100740, 100788, 100835, 100882, 100930, 100977, 101025, 100563, 100694, 100741, 100789, 100836, 100883, 100931, 100978, 101026, 100566, 100695, 100742, 100790, 100837, 100884, 100932, 100979, 101027, 100567, 100696, 100743, 100791, 100838, 100885, 100933, 100980, 101028, 100573, 100697, 100744, 100792, 100839, 100886, 100934, 100982, 101029, 100575, 100698, 100745, 100793, 100840, 100887, 100935, 100983, 101030, 100577, 100699, 100746, 100794, 100841, 100888, 100936, 100984, 101040, 100578, 100700, 100747, 100795, 100842, 100889, 100937, 100985, 101041, 100585, 100701, 100748, 100796, 100843, 100890, 100938, 100986, 101042, 100591, 100702, 100749, 100797, 100844, 100891, 100939, 100987, 101043, 100595, 100703, 100750, 100798, 100845, 100892, 100940, 100988, 101044, 100596, 100704, 100751, 100799, 100846, 100893, 100941, 100989, 101045, 100603, 100705, 100752, 100800, 100847, 100894, 100942, 100990, 101046, 100604, 100706, 100753, 100801, 100848, 100895, 100943, 100991, 101047, 100607, 100707, 100754, 100802, 100849, 100896, 100944, 100992, 101048, 100608, 100708, 100755, 100803, 100850, 100897, 100945, 100993, 101049, 100609, 100709, 100756, 100804, 100851, 100898, 100946, 100994, 101050, 100610, 100710, 100757, 100805, 100852, 100899, 100947, 100995, 101051, 100611, 100711, 100758, 100806, 100853, 100900, 100948, 100996, 101052, 100612, 100712, 100759, 100807, 100854, 100901, 100949, 100997, 101053, 100613, 100713, 100760, 100808, 100855, 100902, 100950, 100998, 101054, 100628, 100714, 100761, 100809, 100856, 100903, 100951, 100999, 101055, 100629, 100715, 100762, 100810, 100857, 100904, 100952, 101000, 101056, 100630, 100716, 100763, 100811, 100858, 100905, 100953, 101001, 101057, 100631, 100717, 100764, 100812, 100859, 100906, 100954, 101002, 101058, 100633, 100718, 100765, 100813, 100860, 100907, 100955, 101003, 101059, 100634, 100719, 100766, 100814, 100861, 100908, 100956, 101004, 101060, 100635, 100720, 100767, 100815, 100862, 100910, 100957, 101008, 101061, 100638, 100721, 100768, 100816, 100863, 100911, 100958, 101009, 101062, 100668, 100722, 100769, 100817, 100864, 100912, 100959, 101010, 101063, 100669, 100723, 100770, 100818, 100865, 100913, 100960, 101011, 101064, 100670, 100724, 100771, 100819, 100866, 100914, 100961, 101012, 101065, 100671, 100725, 100772, 100820, 100867, 100915, 100962, 101013, 101066, 100672, 100726, 100773, 100821, 100868, 100916, 100963, 101014, 101067, 100673, 100727, 100774, 100822, 100869, 100917, 100964, 101015, 101068, 100681, 100728, 100775, 100823, 100870, 100918, 100965, 101016, 100682, 100729, 100776, 100824, 100871, 100919, 100966, 101017, 100683, 100730, 100777, 100825, 100872, 100920, 100967, 101018, 100684, 100731, 100778, 100826, 100873, 100921, 100968, 101005, 100685, 100732, 100780, 100827, 100874, 100922, 100969, 101006, 100686, 100733, 100781, 100828, 100875, 100923, 100970, 101007, 100687, 100734, 100782, 100829, 100876, 100924, 100971, 101019, 100688, 100735, 100783, 100830, 100877, 100925, 100972, 101020

Distribution pattern: United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.