Stanley Security Solutions Inc: M200 Fall Monitoring System

Recall number

Z-1349-2019

Recalling firm

Stanley Security Solutions Inc

Product

M200 Fall Monitoring System

Status

Terminated

Initiated

2018-10-11

Posted

not on file

Terminated

2020-04-10

Reason

Damaged capacitor on the printed circuit board.

Root cause

Under Investigation by firm

Action

On October 11, 2018 Stanley Healthcare sent via e-mail notification of the recall with the following instructions: PLEASE IMPLEMENT THE FOLLOWING PROCEDURE IMMEDIATELY: 1. Contact Stanley at 800-206-1045 immediately to begin locating affected monitors and to request replacement monitors. Stanley is prepared to provide you with the shipping and order information for the order(s) that may be affected. Any affected monitors that are not in use should be quarantined immediately for return and should not be placed in service. Additionally, if you distributed this monitor to others, please identify them and notify them immediately of this product recall. Please provide them with a copy of this Recall Notice. During this call with Stanley, you will obtain an advance Return Merchandise Authorization number. New monitors will be shipped to you at no charge, and arrangements will be made to return affected monitors to Stanley for further investigation. 2. Return Product through Customer Service After receiving replacement monitors, replace all affected monitors identified below, and return them to Stanley using the Return Merchandise Authorization number and instructions that were issued to you when replacements were ordered. 3. Certification of Products Return IMPORTANT! Upon return of all affected monitors, the person in authority at the facility must sign the appropriate acknowledgement signature block listed below and return the fully executed Recall Notice to: Mr. Garth Jack Sr. QA, EHS, & Compliance Manager 4600 Vine Street Lincoln, NE 68503 Phone: 402-742-9335

Quantity

1101

Distribution

CT, FL, OH, OK, TX, WA, and WV Canada

Lot, serial or model codes

Serial Numbers: 68015, 68016, 68017, 68018, 68019, 68020, 68021, 68022, 68023, 68024, 68025, 68026, 68027, 68028, 68029, 68030, 68031, 68032, 68033, 68034, 68035, 68036, 68037, 68038, 68039, 68040, 68041, 68042, 68043, 68044, 68045, 68046, 68047, 68048, 68049, 68050, 68721, 68722,  68723, 68724, 68725, 68726, 68727, 68728, 68729, 68730, 68731, 68732, 68733, 68734, 68735, 68736, 68737, 68738, 68739, 68740, 68741, 68742, 68743, 68744, 68745, 68746, 68747, 68748, 68749, 68750, 68769, 68770, 68771, 68772, 68773, 68774, 68775, 68776, 68777, 68778, 68779, 68780, 68793, 68794, 68795, 68796, 68797, 68798, 68799, 68800, 68801, 68802, 68803, 68816, 68817, 68818, 68819, 68820, 68821, 68822, 68823, 68824, 68825, 68826, 68827, 68828, 68829, 68830, 68831, 68832, 68833, 68834, 68835, 68836, 68837, 68838, 68839, 69662, 69663, 69664, 69665, 69666, 69667, 69668, 69669, 69670, 69671, 69672, 69673, 69674, 69675, 69676, 69677, 69678, 69679, 69680, 69681, 69682, 69683, 69684, 69685, 69698, 69699, 69702, 69703, 69704, 69706, 69708, 69924, 69925, 69926, 69927, 69928, 69929, 69930, 69932, 69933, 69934, 69935, 69936, 69937, 69938, 69939, 69941, 69942, 70113, 70122, 70123, 70124, 70125, 70126, 70127, 70128, 70129, 70130, 70131, 70132, 70133, 70135, 70136 70137 ,70138, 70139, 70140, 70141, 70142, 70143, 70144, 70145, 70182, 70183, 70184, 70185, 70282, 70283, 70284, 70285, 70286, 70287, 70288, 70289, 70290, 70291, 70293, 70294, 70295, 70296, 70297, 70298, 70299, 70301, 70302, 70320, 70327, 70328, 70329, 70330, 70331, 70332, 70333, 70334, 70335 70336, 70337, 70338, 70394, 70456, 70519, 70520, 70521, 70522, 70523, 70525, 70526, 70527, 70528, 70529, 70530, 70531, 70532, 70533, 70534, 70535, 70536, 70537, 70538, 70539, 70540, 70541, 70542, 70543, 70544, 70545, 70546, 70547, 70548, 70549, 70550, 70551, 70552, 70553, 70554, 70620, 70621, 70622, 70623, 70624, 70625, 70626, 70627, 70628, 70629, 70630, 70631, 70632, 70633, 70634, 70635, 70636, 70637, 70638, 70794, 70796, 70797, 70798, 70799, 70800, 70801, 70802, 70803, 70804, 70938, 70939, 70940, 70941, 70942, 70943, 70944, 70945, 70946, 70947, 70948, 70949, 70950, 70951, 70952, 70953, 70954, 70955, 70956, 70957, 70958, 70959, 70960,70961,70962,70963, 70964,70965,70966,70967,70968,70969,70970,70971,70972,70973,70974,70975,70976,70977,70978, 70979,70980,70981,70982,70983,70984,70985,70986,70987,70988,70989,70990,70991,70992,70993, 70994,70995,70996,70997,70998,70999,71000,71001,71002,71003,71004,71005,71006,71007,71008, 71009,71034,71035,71036,71037,71038,71039,71040,71041,71042,71043,71044,71045,71046,71047, 71048,71049,71050,71051,71052,71053,71054,71055,71056,71080,71081,71082,71083,71084,71085, 71086,71087,71088,71089,71090,71091,71092,71093,71094,71095,71096,71097,71098,71099,71100, 71377,71378,71379,71380,71381,71382,71383,71384,71385,71386,71387,71388,71389,71390,71391, 71392,71393,71394,71395,71396,71397,71398,71399,71400,71401,71402,71403,71404,71405,71406, 71407,71408,71409,71410,71411,71412,71413,71414,71415,71416,71417,71418,71419,71420,71421, 71422,71423,71424,71425,71426,71427,71428,71429,71430,71431,71432,71433,71434,71471,71472, 71473,71474,71475,71476,71477,71478,71479,71480,71481,71482,71483,71484,71485,71486,71487, 71488,71489,71490,71491,71492,71493,71494,71519,71520,71521,71522,71523,71524,71525,71526, 71527,71528,71529,71530,71543,71544,71545,71546,71547,71548,71549,71550,71551,71552,71553, 71554,71567,71568,71569,71570,71571,71572,71573,71574,71575,71576,71577,71578,71603,71604, 71605,71606,71607,71608,71609,71610,71611,71612,71613,71614,71615,71616,71617,71618,71619, 71620,71621,71622,71623,71624,71625,71626,71639,71640,71641,71642,71643,71644,71645,71646, 71647,71648,71649,71650,71651,71652,71653,71654,71655,71656,71657,71658,71659,71660,71661, 71662,71687,71688,71689,71690,71691,71692,71693,71694,71695,71696,71697,71698,71699,71700, 71701,71702,71703,71704,71705,71706,71708,71709,71710,71711,71712,71713,71714,71715,71716, 71717,71718,71719,71720,71721,71722,71723,71724,71725,71726,71727,71728,71764,71765,71766, 71767,71768,71769,71770,71771,71772,71773,71774,71775,71776,71777,71778,71779,71780,71781, 71782,71783,71784,71785,71786,71787,71800,71801,71802,71803,71804,71805,71806,71807,71808, 71809,71810,71811,71872,71873,71874,71875,71876,71877,71878,71879,71880,71881,71882,71883, 71884,71885,71886,71887,71888,71889,71890,71891,71892,71893,71894,71895,71896,71897,71898, 71899,71900,71901,71902,71903,71904,71905,71906,71907,71908,71909,71910,71911,71912,71913, 71914,71915,71916,71917,71918,71967,71968,71969,71970,71971,71972,71973,71974,71975,71976, 71977,71978,71979,71980,71981,71982,71983,71984,71985,71986,71987,71988,71989,71990,71991, 71992,71993,71994,71995,71996,71997,71998,71999,72000,72001,72002,72015,72016,72017,72018, 72019,72020,72021,72022,72023,72024,72025,72026,72027,72028,72029,72030,72031,72032,72033, 72034,72035,72036,72049,72050,72051,72052,72053,72054,72055,72056,72057,72058,72059,72060, 72061,72062,72063,72064,72065,72066,72067,72068,72069,72070,72071,72072,72095,72096,72097, 72098,72099,72100,72101,72102,72103,72105,72106,72225,72311,72312,72325,72326,72327,72328, 72329,72330,72331,72332,72333,72334,72335,72336,72565,72566,72567,72568,72569,72570,72571, 72572,72573,72574,72575,72577,72578,72579,72580,72581,72582,72583,72584,72585,72586,72587, 72588,72625,72626,72627,72628,72629,72630,72631,72632,72633,72634,72635,72636,72639,72640, 72641,72642,72653,72673,72674,72675,72676,72677,72678,72679,72680,72681,72682,72683,72684, 72694,72733,72734,72735,72736,72737,72738,72739,72740,72741,72742,72743,72744,72745,72746, 72747,72748,72749,72750,72751,72752,72753,72754,72755,72756,72817,72818,72819,72820,72821, 72822,72823,72824,72825,72826,72827,72828,72841,72842,72843,72844,72845,72846,72847,72848, 72849,72850,72851,72852,72861,72995,72997,72998,72999,73000,73001,73002,73003,73004,73005, 73006,73007,73008,73009,73010,73012,73013,73014,73015,73016,73017,73018,73019,73020,73021, 73022,73023,73024,73025,73026,73027,73028,73029,73030,73031,73032,73033,73034,73035,73036, 73037,73038,73039,73040,73041,73042,73043,73044,73045,73046,73047,73048,73049,73050,73051, 73052,73053,73054,73055,73056,73057,73058,73059,73060,73061,73062,73063,73064,73065,73066, 73103,73104,73105,73106,73107,73108,73109,73110,73111,73112,73113,73114,73115,73116,73117, 73118,73119,73120,73121,73122,73123,73124,73125,73161,73162,73163,73164,73165,73166,73167, 73168,73169,73170,73171,73172,73173,73174,73175,73176,73177,73178,73179,73180,73181,73182, 73183,73184,73185,73186,73187,73188,73189,73190,73191,73192,73193,73194,73195,73196,73197, 73198,73199,73200,73201,73202,73203,73204,73224,73226,73251,73252,73253,73255,73256,73257, 73258,73259,73260,73261,73262,73322,73323,73324,73325,73326,73327,73328,73329,73330,73331, 73332,73333,73334,73335,73336,73337,73338,73339,73340,73341,73342,73343,73344,73345,73346, 73347,73348,73349,73350,73351,73352,73353,73354,73355,73356,73357,73358,73359,73360,73361, 73362,73363,73364,73365,73366,73367,73368, and 73369.

510(k) numbers

not on file

PMA numbers

not on file

Product code

KMI

Firm FEI

1929691

Firm city

Lincoln

Firm state

NE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy