Events

Rappel de HD11

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37888
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0987-2007
  • Date de mise en oeuvre de l'événement
    2007-04-25
  • Date de publication de l'événement
    2007-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52082
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Diagnostic Ultrasound System - Product Code IYN
  • Cause
    Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. if the user exits an imaging mode while active annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib.
  • Action
    On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.

Device

HD11
  • Modèle / numéro de série
    DOMESTIC SERIAL NUMBERS:   US10670272, US10670282, US10670288, US10670296, US10670304, US10670314, US10670315, US10670316, US10670317, US10670319, US10771576, US10771580, US10771596, US10771610, US10771620, US10771621, US10771622, US10771623, US10771630, US10771631, US10771638, US10771640, US10771641, US10771647, US10771651, US10771658, US10771660, US10771661, US20530061, US20530091, US20670366, US20670392, US20670393, US20771672, US20771674, US20771675, US20771683, US20771685, US20771686, US20771688, US20771689, US20771696, US20771697, US20771718, US20771722, US20771725, US20771726, US20771729, US20771733, US20771734, US20771735, US20771738, US20771739, US20771749, US30670410, US30670411, US30670501, US30670502, US30670509, US30670521, US30771757, US30771757, US30771766, US30771771, US30771772, US30771774, US30771775, US30771782, US30771790, US30771793, US30771809, US30771827, US30771830, US30771831, US30771835, US30771847, US30771848, US30771858, US30771862, US30771865, US40670540, US40670541, US40670573, US40670600, US40670624, US50670631, US50670657, US50670673, US50670707, US50670737, US60530418, US60670757, US60670777, US60670840, US60670841, US60670861, US60670862, US60670872, US60670873, US60670879, US60670880, US70670906, US70670912, US70670913, US70670914, US70670915, US70670947, US70670953, US70670955, US70670975, US80670986, US80670987, US80670990, US80670991, US80670992, US80670997, US80671008, US80671039, US80671040, US80671079, US80671083, US80671084, US90404706, US90531014, US90531073, US90671117, US90671154, US90671161, US90671165, US90671170, US90671178, USD0531367, USD0570096, USD0570114, USD0570161, USD0570195, USD0570200, USD0570207, USD0671475, USD0671490, USD0671493, USD0671497, USD0671498, USD0671503, USD0671504, USD0671505, USD0671510, USD0671511, USD0671527, USD0671531, USD0671532, USD0671533, USD0671542, USD0671546, USD0671547, USD0671548, USD0671550, USD0671553, USD0671554, USD0671555, USD0671556, USD0671567, USD0671572, USN0531226, USN0531237, USN0531243, USN0531256, USN0570005, USN0570014, USN0570031, USN0570036, USN0570044, USN0671319, USN0671320, USN0671321, USN0671322, USN0671323, USN0671325, USN0671326, USN0671341, USN0671351, USN0671352, USN0671353, USN0671360, USN0671362, USN0671367, USN0671370, USN0671378, USN0671406, USN0671407, USN0671408, USN0671410, USN0671413, USN0671414, USN0671418, USN0671422, USN0671423, USO0531081, USO0531087, USO0671212, USO0671214, USO0671254, USO0671260, USO0671263, USO0671271, USO0671285, USO0671286, USO0671287, USO0671288, USO0671289, USO0671290, USO0671291, USO0671293, USO0671294, USO0671304, USO0671311, USO0671315, USO0671316, and USO0671317.    INTERNATIONAL SERIAL NUMBERS:  US10670302, US10732432, US10771574, US10771578, US10771588, US10771590, US10771591, US10771593, US10771594, US10771595, US10771597, US10771599, US10771601, US10771603, US10771606, US10771607, US10771608, US10771612, US10771617, US10771628, US10771629, US10771632, US10771633, US10771635, US10771636, US10771639, US10771644, US10771646, US10771649, US10771652, US10771654, US10771655, US10771656, US10771657, US10771662, US10771666, US10771667, US10771669, US10771671, US20670326, US20771673, US20771678, US20771680, US20771681, US20771687, US20771691, US20771695, US20771699, US20771701, US20771708, US20771713, US20771714, US20771715, US20771716, US20771727, US20771728, US20771744, US20771747, US30670469, US30670525, US30771756, US30771756, US30771758, US30771759, US30771768, US30771778, US30771780, US30771786, US30771788, US30771792, US30771797, US30771800, US30771802, US30771805, US30771807, US30771810, US30771811, US30771812, US30771815, US30771816, US30771818, US30771819, US30771820, US30771828, US30771832, US30771833, US30771836, US30771837, US30771840, US30771842, US30771843, US30771845, US30771846, US30771849, US30771853, US30771861, US30771861, US40631672, US40670548, US40670551, US40670575, US40670576, US40670577, US50530353, US50670674, US50670745, US60670785, US60670812, US60670813, US60670888, US70670905, US70670911, US70670920, US80530793, US80530809, US80671003, US80671014, US80671074, US80671082, US90671125, US90671175, US90671176, US90671183, US90671192, US90671195, USD0570097, USD0570116, USD0570121, USD0570149, USD0570154, USD0570155, USD0570166, USD0570169, USD0570171, USD0671440, USD0671441, USD0671442, USD0671443, USD0671444, USD0671445, USD0671446, USD0671447, USD0671448, USD0671449, USD0671450, USD0671451, USD0671452, USD0671453, USD0671454, USD0671455, USD0671457, USD0671458, USD0671459, USD0671460, USD0671461, USD0671462, USD0671463, USD0671464, USD0671465, USD0671466, USD0671467, USD0671468, USD0671469, USD0671470, USD0671471, USD0671472, USD0671473, USD0671474, USD0671476, USD0671477, USD0671478, USD0671479, USD0671480, USD0671481, USD0671482, USD0671483, USD0671484, USD0671485, USD0671486, USD0671487, USD0671488, USD0671489, USD0671491, USD0671492, USD0671494, USD0671495, USD0671496, USD0671499, USD0671500, USD0671501, USD0671502, USD0671506, USD0671507, USD0671508, USD0671509, USD0671512, USD0671513, USD0671514, USD0671515, USD0671516, USD0671517, USD0671518, USD0671519, USD0671520, USD0671521, USD0671522, USD0671523, USD0671524, USD0671525, USD0671534, USD0671537, USD0671538, USD0671543, USD0671544, USD0671545, USD0671562, USD0671563, USD0671566, USN0570007, USN0570008, USN0570009, USN0570055, USN0570056, USN0570057, USN0671324, USN0671327, USN0671328, USN0671329, USN0671330, USN0671331, USN0671332, USN0671333, USN0671334, USN0671335, USN0671336, USN0671337, USN0671338, USN0671339, USN0671340, USN0671342, USN0671343, USN0671344, USN0671345, USN0671346, USN0671347, USN0671348, USN0671349, USN0671354, USN0671355, USN0671356, USN0671357, USN0671358, USN0671359, USN0671361, USN0671363, USN0671364, USN0671365, USN0671366, USN0671368, USN0671369, USN0671371, USN0671372, USN0671373, USN0671374, USN0671375, USN0671376, USN0671379, USN0671380, USN0671381, USN0671382, USN0671383, USN0671384, USN0671385, USN0671386, USN0671387, USN0671388, USN0671389, USN0671390, USN0671391, USN0671392, USN0671393, USN0671394, USN0671395, USN0671396, USN0671397, USN0671398, USN0671399, USN0671400, USN0671401, USN0671402, USN0671403, USN0671404, USN0671405, USN0671409, USN0671411, USN0671412, USN0671415, USN0671416, USN0671417, USN0671419, USN0671420, USN0671421, USN0671424, USN0671426, USN0671427, USN0671428, USN0671429, USN0671430, USN0671431, USN0671432, USN0671433, USN0671434, USN0671435, USN0671436, USN0671437, USN0671438, USN0671439, USO0531134, USO0531137, USO0671213, USO0671215, USO0671279, USO0671280, USO0671281, USO0671282, USO0671283, USO0671284, USO0671292, USO0671295, USO0671296, USO0671297, USO0671298, USO0671299, USO0671300, USO0671301, USO0671302, USO0671303, USO0671305, USO0671306, USO0671307, USO0671308, USO0671309, USO0671310, USO0671312, USO0671313, USO0671314, and USO0671318.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide.
  • Description du dispositif
    HD11XE Diagnostic Ultrasound System
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Adresse du fabricant
    Philips Medical Systems, 22100 Bothell-Everett Hwy., P.O. Box 3003, Bothell WA 98041-3003
  • Source
    USFDA