510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-0943-2009

Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920)...

Stryker Medical / initiated 2009-01-05 / Terminated / root cause: design
FDA source (opens on fda.gov)

Stryker Medical Div. of Stryker Corporation began a recall of Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0943-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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. Also, the "hold" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to ho
Root cause tag
design
FDA root cause
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.
Product codes and lots
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.