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U.S. Department of Health and Human Services

Class 2 Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems

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 Class 2 Recall
Motorized Height Ceiling Suspensions (MCS) for CV Xray systems
see related information
Date Posted August 11, 2010
Recall Status1 Terminated on December 02, 2010
Recall Number Z-2210-2010
Recall Event ID 48992
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product 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.
Code Information 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, 534440, 534452, 534476, 534477, 534478, 534479, 534545, 534569, 534634, 534638, 534639, 534646, 534665, 534678, 534681, 534682, 534702, 534716, 534717, 534720, 534724, 534730, 534731, 534756, 534758, 534787, 534796, 534798, 534810, 534811, 534856, 534874, 534876, 534879, 534927, 534928, 534941, 535094, 535151, 535152, 535173, 535202, 535212, 535213, 535224, 535250, 535274, 535278, 535285, 535285, 535303, 535326, 535341, 535342, 535367, 535376, 535387, 535396, 535400, 535415, 535416, 535418, 535424, 535439, 535492, 535566, 535611, 535614, 535615, 535635, 535667, 535702, 535727, 535728, 535761, 535769, 535777, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535979, 535982, 536006, 536007, 536014, 536028, 536030, 536031, 536034, 536035, 536037, 536042, 536067, 536090, 536136, 536138, 536154, 536155, 536163, 536171, 536173, 536174, 536178, 536353, 536379, 536433, 536592, 536639, 536641, 536646, 536714, 536715, 536717, 536721, 536736, 536777, 536789, 536796, 536798, 536801, 536899, 536901, 536921, 536954, 536966, 536993, 537024, 537065, 537073, 537083, 537175, 537205, 537266, 537268, 537296, 537357, 537386, 537466, 537514, 537588, 537589, 537590, 537593, 537597, 537604, 537631, 537644, 537698, 537717, 537743, 537745, 537784, 537804, 537805, 537838, 537854, 537855, 537922, 537934, 537935, 537937, 537938, 537985, 538028, 538084, 538095, 538099, 538102, 538132, 538157, 538172, 538193, 538194, 538228, 538234, 538322, 538368, 538369, 538386, 538387, 538404, 538406, 538409, 538416, 538449, 538464, 538465, 538466, 538479, 538481, 538482, 538485, 538486, 538512, 538514, 538516, 538538, 538744, 538763, 538771, 538806, 538813, 538902, 538903, 538910, 538911, 539094, 539099, 539107, 539204, 539213, 539220, 539224, 539267, 539268, 539322, 539323, 539326, 539369, 539380, 539381, 539398, 539455, 539456, 539472, 539479, 539480, 539516, 539595, 539628, 539634, 539641, 539745, 540016, 540048, 540070, 540082, 540150, 540167, 540184, 540203, 540213, 540237, 540269, 540275, 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, 547748, 547749, 547752, 547753, 547761, 547762, 547763, 547769, 547770, 547777, 547795, 547800, 547822, 547823, 547833, 547838, 547852, 547855, 547861, 547878, 547893, 547896, 547898, 547908, 547914, 547918, 547921, 547922, 547925, 547932, 547948, 547952, 547965, 547976, 547977, 548005, 548020, 548022, 548029, 548036, 548038, 548039, 548049, 548051, 548054, 548061, 548067, 548082, 548108, 548140, 548147, 548288, 548383, 548432, 548496, 548525, 548601, 548603, 548616, 548618, 548640, 548645, 548764, 548775, 548778, 548785, 548966, 549013, 549170, 549202, 549245, 549250, 549252, 549253, 549306, 549368, 549370, 549378, 549379, 549385, 549400, 549451, 549738, 549750, 549792, 549902, 549903, 549925, 549967, 550031, 550053, 550122, 550124, 550133, 550172, 550173, 550198, 550244, 550253, 550255, 550304, 550360, 550371, 550404, 550451, 550691, 550758, 550812, 550935, 551050, 551051, 551178, 551340, 551370, 551379, 551607, 551608, 551633, 551725, 551763, 551851, 551853, 551855, 552178, 552192, 552202, 552279, 552355, 552381, 552382, 552425, 552440, 552469, 552470, 552518, 552546, 552585, 552586, 552590, 552599, 552639, 552736, 552969, 553097, 553137, 553234, 553288, 553351, 553352, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553697, 553699, 553723, 553766, 553798, 553803, 553846, 553867, 553868, 553869, 553871, 553873, 553881, 553921, 553925, 553964, 553981, 553984, 554018, 554049, 554054, 554370, 554427, 554431, 554442, 554444, 554447, 554499, 554518, 554556, 554631, 554680, 554731, 554763, 554775, 554776, 554791, 554802, 554811, 555055, 555206, 555293, 555299, 555321, 555343, 555349, 555350, 555356, 555420, 555447, 555605, 555742, 555834, 555927, 556156, 556311, 556323, 556390, 556470, 556601, 556701, 556708, 556709, 556760, 556773, 556783, 556808, 556814, 556820, 556855, 556857, 557512, 558180, 558180, 558238, 558267, 558448, 558582, 560060, 41445816, 45321194, 49599013, 536234/709270, and 707730/532614.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Bob Pettis
425-487-7469
Manufacturer Reason
for Recall
Monitor ceiling carriage may separate from the monitor ceiling suspension.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Quantity in Commerce 1111 units
Distribution United States and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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