Class 2 Device Recall M200 Fall Monitoring System

• Date Initiated by Firm: October 11, 2018
• Create Date: May 15, 2019
• Recall Status: Terminated on April 10, 2020
• Recall Number: Z-1349-2019
• Recall Event ID: 81425
• Product Classification: Monitor, bed patient - Product Code KMI
• Product: M200 Fall Monitoring System
• Code Information: 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, 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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.
• Recalling Firm/ Manufacturer: Stanley Security Solutions Inc; 4600 Vine St; Lincoln NE 68503-2823
• For Additional Information Contact: Mr. Paul Hall; 402-742-9419
• Manufacturer Reason for Recall: Damaged capacitor on the printed circuit board.
• FDA Determined 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
• 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.