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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