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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3239-2017

IVEA Product Part Number 16100 Model 500A

Publicado el 11 de octubre de 2017 · Inicio del retiro: 24 de agosto de 2017

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Other

Detalles del retiro

Fabricante
Firefly Medical, Inc.
Distribuidor
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Lote
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
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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