Z-1349-2019Class II

M200 Fall Monitoring System

Name: Z-1349-2019 M200 Fall Monitoring System
Creator: Stanley Security Solutions Inc
Published: 2018-10-11
License: https://open.fda.gov/license/

Securitas Healthcare LLC / initiated 2018-10-11 / Terminated

FDA source

Stanley Security Solutions Inc began a recall of M200 Fall Monitoring System on 2018-10-11. FDA classified it as Class II and gives the reason as "Damaged capacitor on the printed circuit board". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1349-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-11
Posted: 2019-05-15
Terminated: 2020-04-10
Recalling firm: Securitas Healthcare LLC
Product: M200 Fall Monitoring System
Product code: KMI Monitor, Bed Patient
Reason for recall: Damaged capacitor on the printed circuit board.
FDA 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 in commerce: 1101
Distribution: CT, FL, OH, OK, TX, WA, and WV Canada
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1349-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1349-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15

Product code KMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)