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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker InTouch Critical Care Bed

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  Class 2 Device Recall Stryker InTouch Critical Care Bed see related information
Date Initiated by Firm January 05, 2009
Date Posted February 25, 2009
Recall Status1 Terminated 3 on November 05, 2010
Recall Number Z-0941-2009
Recall Event ID 49610
Product Classification ELECTRIC ICU BED; MULTIPLE - Product Code FNL
Product Stryker InTouch 1.0 Zoom Critical Care Bed; Model 2140.

The device is intended to be used as an Intensive Care Unit bed.
Code Information Serial Numbers: T01014, T01015, T01016, T01017, T01018, T01019, T01020, T01021, T01022, T01023, T01024, T01025, T01026, T01027, T01028, T01029, T01030, T01031, T01032, T01033, T01034, T01035, T01036, T01038, T01039, T01040, T01041, T01042, T01043, T01044, T01045, T01046, T01047, T01048, T01049, T01050, T01051, T01052, T01053, T01054, T01055, T01056, T01057, T01059, T01060, T01061, T01062, T01063, T01064, T01065, T01067, T01068, T01069, T01070, T01071, T01072, T01073, T01074, T01075, T01076, T01078, T01079, T01080, T01081, T01082, T01083, T01084, T01085, T01086, T01087, T01088, T01089, T01090, T01091, T01092, T01093, T01094, T01095, T01096, T01098, T01100, T01101, T01102, T01103, T01104, T01105, T01106, T01107, T01108, T01109, T01110, T01111, T01112, T01113, T01114, T01115, T01116, T01117, T01118, T01119, T01120, T01121, T01122, T01123, T01124, T01125, T01126, T01127, T01128, T01129, T01130, T01131, T01132, T01133, T01134, T01135, T01136, T01137, T01138, T01139, T01140, T01141, T01142, T01143, T01144, T01145, T01146, T01147, T01148, T01149, T01150, T01152, T01153, T01154, T01155, T01157, T01158, T01159, T01160, T01161, T01162, T01163, T01164, T01165, T01166, T01167, T01168, T01171, T01172, T01173, T01174, T01175, T01176, T01177, T01178, T01179, T01180, T01181, T01182, T01183, T01184, T01185, T01186, T01187, T01188, T01189, T01190, T01191, T01192, T01193, T01194, T01195, T01196, T01197, T01198, T01199, T01200, T01201, T01202, T01203, T01204, T01205, T01206, T01207, T01208, T01209, T01210, T01212, T01213, T01214, T01216, T01217, T01218, T01219, T01220, T01221, T01222, T01223, T01224, T01225, T01226, T01227, T01228, T01230, T01231, T01232, T01233, T01234, T01235, T01236, T01237, T01238, T01239, T01240, T01241, T01242, T01243, T01244, T01245, T01246, T01247, T01248, T01249, T01250, T01251, T01252, T01253, T01254, T01255, T01256, T01257, T01258, T01259, T01260, T01261, T01262, T01263, T01264, T01265, T01266, T01267, T01268, T01269, T01270, T01271, T01272, T01273, T01274, T01275, T01276, T01277, T01278, T01279, T01280, T01281, T01282, T01283, T01284, T01285, T01286, T01287, T01288, T01289, T01290, T01291, T01292, T01293, T01294, T01295, T01296, T01297, T01298, T01299, T01300, T01301, T01302, T01303, T01304, T01305, T01306, T01307, T01308, T01309, T01311, T01312, T01313, T01314, T01315, T01316, T01317, T01318, T01319, T01333, T01334, T01350, T01351, T01352, T01353, T01354, T01355, T01356, T01357, T01358, T01359, T01360, T01361, T01362, T01363, T01364, T01365, T01366, T01367, T01378, T01379, T01380, T01381, T01382, T01383, T01389, T01390, T01391, T01392, T01393, T01394, T01395, T01396, T01397, T01398, T01402, T01403, T01420, T01421, T01422, T01423, T01424, T01425, T01426, T01427, T01428, T01429, T01430, T01431, T01432, T01433, T01434, T01435, T01436, T01437, T01438, T01439, T01440, T01441, T01442, T01443, T01444, T01445, T01446, T01447, T01448, T01449, T01450, T01451, T01452, T01453, T01454, T01455, T01456, T01457, T01458, T01459, T01460, T01461, T01462, T01463, T01464, T01465, T01466, T01467, T01468, T01469, T01470, T01471, T01472, T01473, T01474, T01475, T01476, T01477, T01478, T01479, T01480, T01481, T01482, T01483, T01484, T01485, T01486, T01487, T01488, T01489, T01490, T01491, T01492, T01493, T01494, T01495, T01496, T01497, T01498, T01499, T01500, T01501, T01502, T01503, T01504, T01505, T01506, T01507, T01508, T01509, T01510, T01511, T01512, T01513, T01514, T01515, T01516, T01517, T01518, T01519, T01521, T01522, T01523, T01524, T01528, T01529, T01531, T01532, T01533, T01534, T01535, T01536, T01537, T01538, T01539, T01540, T01541, T01542, T01549, T01556, T01557, T01558, T01559, T01560, T01561, T01562, T01563, T01564, T01565, T01566, T01567, T01568, T01569, T01570, T01571, T01573, T01574, T01575, T01576, T01577, T01578, T01579, T01580, T01581, T01582, T01583, T01584, T01585, T01586, T01587, T01588, T01589, T01590, T01591, T01592, T01593, T01594, T01595, T01596, T01597, T01598, T01599, T01600, T01601, T01602, T01603, T01604, T01605, T01606, T01607, T01614, T01616, T01617, T01618, T01619, T01620, T01621, T01622, T01623, T01624, T01625, T01626, T01627, T01628, T01629, T01630, T01631, T01632, T01633, T01634, T01635, T01636, T01637, T01638, T01639, T01640, T01641, T01642, T01643, T01644, T01645, T01646, T01647, T01648, T01649, T01650, T01651, T01652, T01653, T01654, T01655, T01656, T01657, T01658, T01659, T01660, T01666, T01667, T01668, T01669, T01670, T01671, T01672, T01673, T01674, T01675, T01676, T01677, T01678, T01679, T01680, T01681, T01690, T01691, T01692, T01693, T01694, T01700, T01701, T01702, T01703, T01704, T01705, T01706, T01707, T01708, T01709, T01710, T01711, T01712, T01713, T01714, T01715, T01716, T01717, T01724, T01725, T01726, T01727, T01728, T01729, T01730, T01731, T01732, T01733, T01734, T01735, T01736, T01737, T01738, T01739, T01740, T01741, T01742, T01743, T01744, T01745, T01746, T01747, T01748, T01749, T01750, T01751, T01752, T01753, T01754, T01755, T01756, T01757, T01758, T01759, T01760, T01761, T01762, T01763, T01764, T01765, T01766, T01767, T01768, T01769, T01770, T01771, T01772, T01773, T01774, T01775, T01776, T01777, T01778, T01779, T01780, T01781, T01782, T01783, T01784, T01785, T01786, T01787, T01788, T01789, T01790, T01791, T01792, T01793, T01794, T01795, T01796, T01797, T01798, T01799, T01800, T01801, T01802, T01803, T01804, T01805, T01806, T01807, T01808, T01809, T01810, T01811, T01812, T01813, T01814, T01815, T01816, T01817, T01818, T01819, T01820, T01821, T01822, T01823, T01824, T01825, T01826, T01827, T01828, T01829, T01830, T01831, T01832, T01833, T01834, T01835, T01836, T01837, T01838, T01839, T01840, T01841, T01842, T01843, T01844, T01845, T01846, T01847, T01848, T01849, T01850, T01851, T01852, T01853, T01854, T01855, T01856, T01857, T01858, T01859, T01860, T01861, T01862, T01863, T01864, T01865, T01866, T01867, T01868, T01869, T01870, T01871, T01872, T01873, T01874, T01875, T01876, T01877, T01878, T01879, T01880, T01881, T01882, T01883, T01884, T01885, T01886, T01887, T01888, T01889, T01890, T01891, T01892, T01893, T01894, T01895, T01896, T01897, T01898, T01899, T01900, T01901, T01902, T01903, T01904, T01934, T01936,  T01937, T01938, T01939, T01940, T01941, T01942, T01943, T01944, T01945, T01946, T01947, T01968, T01969, T01972, T01973, T01974, T01975, T01976, T01977, T01978, T01979, T01980, T01981, T01982, T01983, T01984, T01985, T01986, T01987, T01988, T01989, T01990, T01991, T01992, T01993, T01994, T01995, T01996, T01997, T01998, T01999, T02000, T02001, T02002, T02003, T02004, T02005, T02006, T02007, T02008, T02009, T02010, T02017, T02018, T02019, T02020, T02021, T02022, T02023, T02024, T02025, T02026, T02027, T02028, T02029, T02030, T02031, T02032, T02033, T02034, T02035, T02037, T02038, T02039, T02040, T02041, T02042, T02043, T02044, T02045, T02046, T02047, T02048, T02049, T02050, T02051, T02052, T02053, T02054, T02055, T02056, T02057, T02069, T02070, T02071, T02072, T02073, T02074, T02079, T02080, T02081, T02082, T02083, T02084, T02085, T02091, T02092, T02093, T02094, T02095, T02096, T02097, T02098, T02099, T02100, T02101, T02102, T02103, T02104, T02105, T02106, T02108, T02109, T02110, T02111, T02112, T02113, T02114, T02115, T02116, T02117, T02118, T02119, T02120, T02121, T02122, T02123, T02124, T02125, T02126, T02127, T02128, T02129, T02130, T02131, T02132, T02133, T02134, T02135, T02136, T02137, T02138, T02139, T02140, T02141, T02142, T02143, T02144, T02145, T02146, T02147, T02148, T02149, T02150, T02151, T02154, T02155, T02156, T02157, T02158, T02159, T02160, T02161, T02162, T02163, T02164, T02165, T02181, T02182, T02183, T02184, T02185, T02186, T02187, T02188, T02189, T02190, T02191, T02192, T02193, T02194, T02195, T02240, T02242, T02277, T02278, T02279, T02280, T02281, T02282, T02283, T02284, T02285, T02286, T02287, T02288, T02289, T02290, T02291, T02292, T02293, T02294, T02295, T02296, T02351, T02352, T02353, T02354, T02355, T02372, T02373, T02374, T02375, T02376, T02377, T02378, T02379, T02380, T02381, T02382, T02383, T02384, T02385, T02386, T02387, T02388, T02389, T02390, T02391, T02392, T02455, T02469, T02505, T02575, T02576, T02577, T02578, T02579, T02580, T02581, T02582, T02583, T02584, T02585, T02586 and T02661.
Recalling Firm/
Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
Manufacturer Reason
for Recall
The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features.
FDA Determined
Cause 2
Device Design
Action Consignees were notified of the problems via letter dated January 5, 2009, advised to check their beds and to take them out of service if the foot board touchscreen displayed a "tilt over range" error, and that a Stryker Medical field service representative would contact them to perform software upgrades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644.
Quantity in Commerce 1,288 of all models
Distribution Worldwide Distribution including USA and countries of Canada, Japan and Switzerland.
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.