Events

Rappel de Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems

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 North America Co. Phillips.

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
    48992
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2210-2010
  • Date de mise en oeuvre de l'événement
    2008-06-26
  • Date de publication de l'événement
    2010-08-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72469
  • 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
    Motorized Height Ceiling Suspension - Product Code IZI
  • Cause
    Monitor ceiling carriage may separate from the monitor ceiling suspension.
  • Action
    On 07/02/08, the firm sent a "Urgent - Device Correction" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user. The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced. Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.

Device

Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems
  • Modèle / numéro de série
    Products are identified as Equipment numbers:  13046, 25934, 34702, 38592, 41455, 44791, 45059, 52463, 62671, 82824, 83667, 85095, 85137, 85190, 85195, 86189, 86341, 86575, 86914, 86981, 87359, 87364, 100788, 101036, 101077, 101612, 101952, 102664, 103147, 103238, 103265, 103270, 103281, 103283, 103380, 103525, 103526, 103562, 103564, 103781, 103891, 104075, 104076, 104077, 104149, 104464, 104497, 104670, 104950, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 105073, 105139, 105140, 105304, 105489, 105598, 105670, 105674, 105779, 105953, 105960, 203880, 215045, 215140, 500038, 504493, 504655, 504666, 504674, 504733, 504742, 504747, 504776, 504779, 505064, 505077, 505111, 505111, 505252, 505271, 505281, 505363, 505421, 505486, 505530, 505538, 505650, 505809, 505858, 505860, 505861, 505876, 505968, 506026, 506049, 506069, 506119, 506169, 506469, 506509, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506778, 519115, 519118, 519136, 519195, 519196, 519197, 519198, 519211, 519534, 519536, 519537, 519548, 519680, 519730, 519733, 519738, 519812, 519894, 519895, 519899, 519901, 520236, 520275, 520309, 520319, 520430, 520431, 520491, 520523, 520524, 520526, 520582, 520598, 520630, 520631, 520632, 520660, 520680, 520681, 520688, 520701, 520755, 520779, 520783, 520793, 520807, 520814, 520948, 520956, 520964, 520977, 521001, 521154, 521221, 521222, 521223, 521311, 521312, 521314, 521315, 521318, 521325, 521463, 521512, 521537, 521545, 521548, 521589, 521650, 521659, 521675, 521711, 521763, 521820, 521853, 521854, 521890, 521892, 522065, 522118, 522119, 522136, 522138, 522155, 522162, 522177, 522243, 522245, 522253, 522293, 522397, 522440, 522446, 522456, 522458, 530361, 530368, 530391, 530392, 530393, 530396, 530421, 530459, 530460, 530463, 530464, 530584, 530653, 530654, 530656, 530660, 530662, 530663, 530664, 530667, 530668, 530669, 530715, 530783, 531649, 531651, 531728, 531752, 531753, 531758, 531760, 531762, 531799, 531808, 531817, 531830, 531834, 531837, 531931, 531939, 531942, 531943, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532074, 532077, 532080, 532148, 532150, 532152, 532172, 532178, 532207, 532215, 532225, 532226, 532227, 532234, 532235, 532239, 532240, 532241, 532244, 532245, 532249, 532262, 532263, 532264, 532292, 532294, 532445, 532532, 532533, 532534, 532535, 532611, 532612, 532613, 532615, 532616, 532617, 532649, 532652, 532799, 532800, 532986, 532990, 533084, 533085, 533278, 533282, 533283, 533284, 533285, 533286, 533287, 533288, 533289, 533290, 533325, 533343, 533395, 533397, 533398, 533401, 533418, 533476, 533541, 533543, 533551, 533567, 533619, 533738, 533762, 533763, 533772, 533796, 533857, 533861, 533897, 533922, 533955, 533956, 533966, 533967, 534108, 534131, 534150, 534152, 534155, 534156, 534158, 534160, 534215, 534217, 534218, 534232, 534237, 534246, 534247, 534250, 534251, 534252, 534255, 534268, 534269, 534270, 534374, 534380, 534418, 534420, 534427, 534431, 534439, 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540284, 540288, 540301, 540311, 540312, 540317, 540321, 540325, 540338, 540374, 540386, 540421, 540456, 540460, 540461, 540487, 540622, 540684, 540721, 540790, 540808, 540841, 540887, 540912, 540930, 540952, 540973, 541026, 541029, 541030, 541046, 541049, 541053, 541080, 541223, 541237, 541238, 541239, 541251, 541253, 541259, 541276, 541509, 541510, 541572, 541577, 541588, 541589, 541590, 541592, 541597, 541657, 541659, 541667, 541715, 541742, 541748, 541783, 541822, 541848, 541873, 541880, 542109, 542113, 542117, 542306, 542382, 542413, 542478, 542486, 542518, 542522, 542526, 542557, 542714, 542744, 542963, 543087, 543194, 543200, 543209, 543213, 543216, 543229, 543289, 543386, 543397, 543398, 543399, 543411, 543444, 543610, 543611, 543690, 543702, 543759, 543762, 543799, 543829, 543850, 543873, 543877, 543879, 543931, 543953, 543971, 543972, 543984, 543988, 543989, 543999, 544005, 544048, 544051, 544052, 544057, 544086, 544103, 544120, 544122, 544130, 544145, 544184, 544306, 544371, 544395, 544433, 544489, 544513, 544543, 544550, 544572, 544600, 544610, 544631, 544635, 544636, 544637, 544655, 544656, 544668, 544728, 544729, 544750, 544844, 544904, 544989, 544990, 544992, 545023, 545024, 545025, 545037, 545052, 545069, 545073, 545090, 545262, 545280, 545282, 545293, 545295, 545296, 545357, 545365, 545395, 545396, 545443, 545487, 545518, 545521, 545539, 545583, 545604, 545640, 545714, 545733, 545749, 545750, 545752, 545753, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545882, 545884, 545905, 545912, 545921, 545941, 545942, 545964, 545966, 545975, 545985, 545991, 545997, 546012, 546013, 546014, 546025, 546060, 546119, 546149, 546201, 546456, 546517, 546569, 546572, 546585, 546586, 546634, 546668, 546693, 546886, 546906, 546908, 546934, 547005, 547058, 547118, 547159, 547165, 547173, 547215, 547234, 547279, 547287, 547321, 547334, 547364, 547406, 547431, 547600, 547601, 547619, 547620, 547621, 547627, 547628, 547642, 547660, 547715, 547720, 547729, 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  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States and Canada.
  • Description du dispositif
    Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. || Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Adresse du fabricant
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA