Class 2 Device Recall TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series

• Date Initiated by Firm: September 23, 2015
• Create Date: October 22, 2015
• Recall Status: Terminated on November 17, 2016
• Recall Number: Z-0154-2016
• Recall Event ID: 72273
• Product Classification: Table, operating-room, ac-powered - Product Code FQO
• Product: TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series; TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
• Code Information: Serial # W62920, W62920, W62919, U61431, V61880, V61879, V61878, V61877, V61865, V61864, V61863, V61862, V61861, V61860, V61859, V61858, V61857, V61856, V62216, V62636, U61281, U61116, U61114, U61113, W62973, W62972, V62440, V62439, V62438, V62437, V62429, V62428, V62427, V62426, V62425, V62424, V62420, V62419, V62412, V62411, T60420, T60499, T60498, T60497, T60496, T60493, T60492, T60491, T60490, T60489, T60488, V62454, V62453, V62452, V62160, V62159, V61808, V61807, U61488, U61480, U61479, U61432, U61358, U61357, U61357, U61356, U61355, U61352, U61351, U61350, U61349, U61338, U61337, U61336, U61335, U61334, U61333, U61332, U61331, U61330, U61329, U61328, U61314, U61313, U61312, U61244, U61242, U61241, U61240, U60273, V61965, V62367, V62306, V61966, V61813, V61812, V61811, V61810, T60099, T60098, T60097, T60096, T60096, T60095, T60092, T60080, T60079, T60075, T60072, T60071, T60070, T60068, T60067, T60065, T60064, T60061, T60061, T60060, T60059, T60053, T60052, T60051, T60050, T60048, T60047, T60047, T60037, T60036, T60035, W62891, W62890, W62967, W62966, W62965, W62964, W62718, W62717, W62716, T60769, U60951, U60950, U60923, U60922, U61048, W62760, W62759, V61048, U61051, U61050, U61049, U61486, U61485, U61484, U61359, W62816, W62815, W62814, W62813, W62812, W62811, W62810, W62808, W62807, W62806, W62805, W62804, W62803, W62802, W62801, W62800, W62799, W62798, W62797, W62796, W62795, W62794, W62793, W60809, U60945, U60944, U60943, U60942, T60727, T60726, T60291, W62761, W62792, W62791, T60028, T60027, T60026, V61830, V61829, V61828, V61827, V61826, V61824, V61823, V61822, V61821, U61211, U61210, V62448, V62377, V62484, V62483, V62482, V62168, V62167, V61975, V61974, V61973, V61972, T60460, U61489, T60760, T60725, T60715, T60714, T60713, T60712, T60711, T60710, T60709, T60708, T60707, T60706, T60705, T60681, T60680, T60679, T60678, T60677, T60676, T60675, T60674, T60673, T60672, T60671, T60670, T60669, T60668, T60667, T60666, T60665, T60664, T60662, T60661, T60660, T60659, T60658, T60657, T60656, T60379, T60378, T60377, T60376, T60375, T60374, T60373, T60372, T60372, T60371, T60370, T60369, T60368, T60367, T60366, T60365, T60364, T60363, T60362, T60361, T60360, T60359, T60358, T60357, T60356, U60984, T60617, T60616, T60615, T60614, T60613, T60612, T60611, T60610, T60609, T60608, T60607, T60606, T60605, T60604, T60603, T60602, T60601, T60600, T60599, T60598, T60597, T60596, T60595, T60594, T60593, T60592, T60591, T60590, T60589, T60588, T60587, T60586, T60585, T60584, T60583, T60582, T60581, T60580, T60579, T60578, T60577, T60576, T60575, T60574, T60573, T60572, T60571, T60570, T60569, T60568, T60567, T60566, T60565, T60564, T60563, T60562, T60561, T60560, T60559, T60558, T60557, T60556, T60555, T60554, T60553, T60552, T60551, T60550, T60549, T60548, T60547, T60546, T60545, T60544, T60543, T60542, T60541, T60540, T60539, T60538, T60537, T60536, T60535, T60534, T60533, T60532, T60531, T60530, T60529, T60528, T60527, T60526, T60525, T60524, T60523, T60522, T60521, T60520, T60519, T60518, T60517, T60516, T60515, T60514, T60513, T60512, T60511, T60510, T60509, T60508, T60507, T60506, T60354, T60353, T60352, T60351, T60350, T60349, T60348, T60347, T60346, T60345, T60344, T60343, T60342, T60341, T60340, T60339, T60338, T60337, T60336, T60335, T60334, T60333, T60332, T60331, T60330, T60329, T60328, T60327, T60326, T60325, T60324, T60323, T60322, T60321, T60320, T60319, T60318, T60317, T60316, T60315, T60314, T60313, T60312, T60311, T60310, T60309, T60308, T60307, T60306, T60305, T60304, T60303, T60302, T60301, T60300, T60299, T60748, T60747, T60746, T60745, U61038, U60987, U60986, U60985, TF442T0750112SOKO 4574, TF442BC0750112SOKO 4573, T60268, T60267, T60266, T60265, T60264, T60263, T60262, T60261, T60260, T60259, T60258, T60257, T60256, T60255, T60254, T60253, T60252, T60251, T60250, T60249, T60248, T60247, T60246, T60245, T60244, T60243, T60242, T60241, T60240, T60239, T60238, T60237, T60236, T60235, T60234, T60233, T60232, T60231, T60230, T60229, T60228, T60227, T60226, T60225, T60224, T60223, T60222, T60221, T60220, T60219, T60218, T60217, T60216, T60215, T60214, T60213, T60212, T60211, T60210, T60209, T60208, T60207, T60206, T60205, T60204, T60203, T60202, T60201, T60200, T60199, T60198, T60197, T60196, T60195, T60194, T60193, T60192, T60191, T60190, T60189, T60188, T60187, T60186, T60185, T60184, T60183, T60182, T60181, T60180, T60179, T60178, T60177, T60176, T60175, T60110, T60109, W62758, W62757, W62756, W62755, W62754, W62753, W62752, W62751, V62481, V62480, U61264, U61263, U61298, U61297, U61279, U61051, U60947, U60946, T60424, T60423, T60422, T60421, T60420, V62632, V62329, V62328, V62327, V62326, V62325, V62324, V62323, V62322, V62321, V62320, V62319, V62318, V62317, V62316, V62315, V62314, V62138, V62137, V61984, V61983, V61982, V61981, U61548, U61547, V62309, V62308, W62918, T60620, T60298, T60297, T60173, V62049, V62048, V61732, V61731, V61730, U61718, U61717, U61716, U61715, U61714, U61713, U61712, U61711, U61710, U61709, U61708, U61707, U61706, U61705, U61704, U61703, U61702, U61701, U61700, U61699, U61698, U61697, U61696, U61695, U61694, U61693, U61692, U61691, U61690, U61689, U61688, U61687, U61686, U61653, U61652, U61651, U61650, U61649, U61648, U61647, U61646, U61645, U61643, U61642, U61641, U61640, U61639, U61638, U61637, U61636, U61635, U61634, U61633, U61632, U61631, U61630, U61629, U61628, U61627, U61626, U61625, U61624, U61623, U61622, U61621, U61620, U61619, U61618, U61617, U61616, U61615, U61614, U61613, U61612, U61611, U61610, U61562, U61561, U61560, U61559, U61558, U61557, U61556, U61555, U61554, U61553, U61552, U61551, U61529, U61528, U61527, U61522, U61521, U61520, U61519, U61518, U61517, U61516, U61515, U61514, U61513, U61512, U61511, U61510, U61509, T60278, T60277, U60883, U60882, W63049, W63048, W63047, W63046, U61253, U61252, V62578, V61854, U60905, U60904, U60903, U60902, U60901, U60900, U60899, U60898, U60897, U60896, U61276, U61275, V62150, V62149, V62147, U61274, U61273, T62148, V61935, V61934, V61933, V61932, V61931, V61930, V61929, V61928, V61927, V61926, V61925, V61924, V61923, V61922, V61921, V61920, V61919, V61918, V61917, V61916, V61915, V61914, V61913, V61912, V61911, V61910, V61909, V61908, V61907, V61906, V61905, V61904, V61903, V61902, V61901, V61900, V61899, V61898, V61897, V61896, V61784, V61783, V61782, V61781, V61780, V61779, V61778, V61777, T60462, T60460, V62069, V62068, V61894, V61893, V61892, V61891, U61370, U61369, V62343, V62342, U61425, U61424, U61423, U61422, U61421, U61420, U61419, U21426, W62976, U61249, U61248, U60970, U60969, U60968, U60967, U60966, U60965, W63077, W63030, W63029, U61176, V62175, V62174, U61247, U61246, V62659, V62658, V62657, V62656, V62655, V62654, V62653, V62652, V62651, V62650, V62649, V62648, V62647, V62646, V62645, V62644, V62201, V62200, V62199, V62198, V62197, V62196, V62195, V62194, V62193, V62192, V62191, V62190, V62189, V62188, V62187, V62186, V62185, V62184, V62183, V62182, V62181, V62180, V62075, V62074, U61278, U61277, V62446, V62403, U61508, U61507, U61506, U61505, T60719, T60718, T60717, U61266, U61265, W62953, W62952, W63012, V62667, V62666, W62835, W62834, U67526, U61111, U61110, T60790, T60789, T60788, T60787, T60786, T60785, T60784, T60783, T60782, T60781, T60780, T60779, U61282, U61316, U61315, V62346, V62345, V62344, W62963, W62962, W62961, W62960, W62959, W62958, W62957, W62956, W62955, V62468, V62467, V62466, V62465, V62464, V62061, T60273, T60803, V62635, V62634, V62690, U60814, U60813, U60812, U61149, U61118, U60814, U60813, U60812, U61245, V61936, V61806, U60962, V62374, V62083, T60809, U61365, U61364, U61363, U61362, U61361, V62209, V62208, V62207, V62206, V62205, V62204, V62203, V62202, W62836, W62969, W62968, T60716, V61963, V61962, V61961, V61960, T60281, T60280, T60279, U61047, U61147, U61469, U61546, U61545, U61544, U61543, U61542, V62305, T60808, U61262, U61261, V61969, V61968, U61053, U61052, U60953, U60952, W63067, W63066, W63065, W63064, W63061, W63060, V61775, V61774, V61773, V61772, V62402, T60122, T60121, T60120, T60119, T60118, T60117, T60116, T60115, T60114, T60113, T60112, T60111, T60100, T60094, T60093, T60078, T60463, T60462, T60461, T60460, T60459, T60141, T60140, T60139, V62496, V62495, V62494, V62493, V62492, V62491, V62490, V62489, V62488, W62989, W62818, W62817, W62729, V62436, V62435, V61726, V61725, V61724, T60778, T60777, T60772, T60771, T60770, U60885, U60884, V62407, V62601, V62600, V62599, V62598, V62597, V62596, V62595, V62592, V62591, V62590, V62589, V62588, V62587, V62565, V62564, V62563, V62562, V62561, V62560, V62559, V62558, V62557, V62556, V62555, V62554, V62553, V62552, V62551, V62550, V62549, V62548, V62547, V62546, V62545, V62544, V62543, V62542, V62541, V62540, V62539, V62538, V62537, V62536, V62535, V62534, V62533, V62532, V62531, V62530, V62529, V62528, V62527, V62526, V62525, V62524, V62523, V62522, V62521, V62520, V62519, V62518, V62511, V62510, V62509, V62508, V62507, V62501, V62500, V62499, V62498, V62497, V62410, V62409, U61254, T60505, T60504, T60503, T60502, U60925, U60924, V62218, V62217, V61818, V61817, V61816, W62890, U61437, U61427, V62085, U61468, V61723, V61721, U60876, U60875, U60874, U60873, W62744, W62743, W62742, V62672, V62671, V62670, V62486, V62463, V62462, V62459, T60153, T60152, T60149, T60148, V62155, V62154, V62153, V62152, V62151, U61493, U61492, U61491, U61490, V62107, V62106, U61133, U61134, U61135, U61136, U61137, U61138, U61139, U61140, U61141, U61142, U61143, U61144, U61145, U61146, V61809, V61776, V62171, V61885, T60270, V62401, V62400, V62399, V62398, V62397, V62396, V62395, V62394, V62393, V62392, V62391, V62390, U60975, U60974, U60973, U60776, V62157, V62156, V62173, V62140, V62139, V62104, V62103, V62102, V62101, V62100, V62099, V62098, V62088, V62087, V62086, V62360, V62359, V62358, V62357, V62356, V62355, V62303, V62302, V62301, V62300, V62299, V62298, V62297, V62296, V62295, V62294, V62293, V62292, V62291, V62290, V62289, V62288, V62287, V62286, V62285, V62284, V62283, V62282, V62281, V62280, V62279, V62278, V62277, V62276, V62275, V62274, V62273, V62272, V62271, V62270, V62269, V62268, V62267, V62266, V62265, V62264, V62258, V62257, V62256, V62255, V62254, V62253, V62252, V62251, V62250, V62249, V62248, V62247, V62246, V62245, V62244, V62243, V62242, V62241, V62240, V62238, V62237, V62236, V62235, V62234, V62233, V62232, V62231, V62230, V62229, V62228, V62227, V62226, V62225, V62224, V62223, V62222, V62221, V62212, W62889, W62888, W62887, W62886, W62885, W62884, W62883, W62882, W62881, W62880, W62879, W62878, W62877, W62876, W62875, W62874, W62873, W62872, W62871, W62870, W62869, W62868, W62867, W62866, W62865, W62864, W62863, W62862, W62861, W62860, W62859, W62858, W62857, W62856, W62855, W62854, W62853, W62852, W62851, W62850, V62665, V62630, V62628, T60091, T60090, T60089, T60088, T60087, T60086, T60189, T60188, T60187, T60186, T60185, T60184, T60183, T60182, T60181, T60180, T60179, T60178, T60177, T60176, T60175, T60174, T60173, T60172, T60171, T60170, T60169, T60168, T60167, T60166, T60165, T60164, T60163, T60162, T60161, T60160, T60159, T60158, T60157, T60156, T60619, T60618, V61815, V61814, T60631, T60630, T60629, T60628, U60964, U60963, W62741, W62739, V62688, V62687, V62686, V62685, V62684, V62683, V62682, V62681, V62330, V61971, V61890, V61889, V61888, V61887, V61886, U61284, U61284, U61283, U61283, W63059, W63058, W63057, W63056, T60135, T60724, T60723, T60722, T60721, W63068, S60004, S60003, W62785, W62784, W62783, W62782, W62781, W62780, W62779, W62778, W62777, W62776, W62775, W62774, W62773, W62772, W62771, W62770, W62769, W62768, W62767, W62766, W62765, W62764, W62763, W62762, V62583, V62582, V62581, V62580, W62917, W62916, W62915, W62914, V62689, W63024, W62987, W62904, W62903, W62902, W62898, W62896, V62073, V62072, V62047, V62046, V62045, U61037, U61036, U61478, U61477, U61476, U61475, U61474, U61473, U61472, U61471, V62577, V62576, V62064, V62063, 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S60002, U60919, U60918, U60879, U60878, U60877, U60810, U61487, V62694, V62693, V62692, V62691, W62720, W62719, U60961, U60960, U60959, U60958, V61802, V61801, V61800, V61799, V61798, V61797, V61796, V61795, V61794, V61793, V61792, V61791, V61790, V61789, V61788, V61787, V61786, V61785, V62060, V62059, V62058, V62057, V62056, V62055, U61215, U61214, U61213, U61212, U61046, U61045, U60851, U60850, U60849, U60848, U60847, U60846, U60845, U60844, U60843, U60842, U60841, U60840, U60839, U60838, U60833, U60832, U60822, U60821, U60820, U60819, U60818, U60817, U60816, U60815, T60416, U60941, U60940, U60939, U60938, U61260, U61259, U61258, U61257, U61256, U61255, V62170, V62169, V61977, V61976, V61955, V61954, V62450, V62449, V62627, V62626, V62625, V62624, V62623, V62622, W63051, V62663, V62143, V62142, V62141, V62472, V62471, V62470, V62362, V62361, T60663, T60402, T60385, T60384, T60443, V62715, V62714, V62713, V62712, V62698, V62697, V62696, V62695, V62221, V62220, V62219, V61895, T60458, T60457, T60456, T60455, W62843, W62842, W62841, W62840, W62839, W62838, W62837, T60454, T60453, T60452, T60451, T60450, T60449, T60448, T60447, T60446, T60445, T60444, T60442, T60441, T60440, T60439, T60438, T60437, T60436, T60435, T60434, T60433, T60432, T60431, T60741, T60735, T60734, T60733, T60732, T60655, T60654, T60653, T60652, T60651, T60650, T60649, T60648, T60647, T60646, T60645, T60644, T60643, T60642 T60641 T60640 T60639 T60638 T60637 T60636 T60635 T60634 T60633 T60632 T60487 T60486 T60485 T60484 T60483 T60482 T60481 T60480 T60479 T60478 T60477 T60476 T60475 T60474 T60473 T60472 T60471 T60470 T60469 T60468 T60467 T60466 T60465 T60464 V62476 V62475 V62474 V62473 V62313 V62312 V62311 V62310 V61841 V62375 U61153 U61152 U61151 U61150 V62457 V62456 V62455 W62738 W62737 W62736 W62735 W62734 W62733 W62732 W62731 W62730 U61368 U61367 U61366 U61272 U61271 U61270 S6022 S60021 S60020 S60019 S60018 S60017 S60016 S60015 S60014 S60013 S60012 S60011 S60010 S60009 S60008 S60007 V62354 V62353 V62352 V62351 V62350 V62349 V62348 V62347 U61550 U61549 U61429 U61311 U61310 U61309 U61308 U61296 U61295 U61294 U61293 U61292 U61291 U61290 U61289 U61288 U61287 U61286 U61285 U61301 U61300 U61299 S60006 S60005 U60957 U60956 T60624 T60623 T60085 T60084 T60083 T60082 TCT60272 T60271 W62833 W62832 W62831 U61630 W62728 V62345 U61501 U61500 U61499 U61498 U61497 U61496 U61495 U61494 T60622 T60108 T60107 T60777 T60776 T60775 T60063 V62517 V62516 V62515 V62514 V62513 V62512 T60501 T60740 W62724 W62723 U61044 U61043 U61042 U61041 U61040 U61039 V61852 V61851 V61850 V61849 V61848 V61847 V61846 V61845 V61844 V61843 V61842 V62210 V62215 V62214 V62213 V62212 V62211 U60868 U60867 U60866 U60865 U60864 V62177 V62178 V62176 V62136 V62135 V62134 V62133 V62132 V62131 V62130 V62129 V62128 V62127 V62126 V62125 V62124 V62123 V62122 V62121 V62120 V62119 V62118 V62117 V62116 V62115 V62114 V62113 V62112 V62111 V62110 V62109 V62108 V62081 V62080 V62079 V62078 V62077 V62076 V62071 V62067 V62066 V62065 V62044 V62043 V62042 V62041 V62040 V62039 V62037 V62036 V62035 V62034 V62033 V62032 V62031 V62030 V62029 V62028 V62027 V62026 V62025 V62024 V62023 V62022 V62021 V62020 V62019 V62018 V62017 V62016 V62015 V62014 V62013 V62012 V62011 V62010 V62009 V62008 V62007 V62006 V62005 V62004 V62003 V62002 V62001 V62000 V61999 V61998 V61997 V61996 V61995 V61994 V61993 V61992 V61991 V61990 V61989 V61988 V61987 V61986 V61985 V61980 V61979 V61978 V61952 V61951 V61950 V61949 V61948 V61947 V61946 V61945 V62179 V61944 V61943 V61942 V61941 V61940 V61939 V61938 V61937 V62711 V62710 V62709 V62708 V62707 V62706 V62705 V62704 V62703 V62702 V62701 V62700 V62699 V61953 W63076 W63075 W63074 W63073 W63072 W63071 W63070 W63069 W63068 W63067 W63066 W63065 T60418 T60415 T60743 T60742 T60414 T60413
• Recalling Firm/ Manufacturer: Berchtold Corp.; 1950 Hanahan Rd; Charleston SC 29406-4878
• For Additional Information Contact: Technical Support; 800-243-5135
• Manufacturer Reason for Recall: During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly.
• FDA Determined Cause: Device Design
• Action: Stryker sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Stryker Representative would visit each account for product inspection. During the inspection the Stryker Representative will remove the control switches and replace them with new control switches. Customers were instructed if any malfunction prior to inspection were noticed customers should call local Technical Support immediately at 800-243-5135.
• Quantity in Commerce: 2129 units
• Distribution: Worldwide Distribution - US (nationwide), Canada, and Germany
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.