FDAFDA · Food and drugs·Recall number Z-1862-2012

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

Published July 4, 2012 · Recall initiated: May 17, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Stryker Medical Division of Stryker Corporation
Distributor: Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and Singapore.
Lot: Model FL25E: QK02276, QK02274, QK01602, KK01602, K03922, K03921, K03920, K03919, K03918, K03917, K03916, K03915, K03914, K03913, K03912, K03911, K03910, K03909, K03908, K03907, K03906, K03905, K03904, K03903, K03902, K03901, K03900, K03899, K03898, K03897, K03896, K03895, K03894, K03893, K03892, K03891, K03890, K03889, K03888, K03887, K03886, K03885, K03884, K03883, K03882, K03881, K03880, K03879, K03878, K03877, K03876, K03875, K03874, K03873, K03872, K03871, K03870, K03869, K03868, K03867, K03866, K03865, K03864, K03863, K03862, K03861, K03860, K03859, K03858, K03857, K03856, K03855, K03854, K03853, K03852, K03851, K03850, K03849, K03848, K03847, K03846, K03845, K03844, K03843, K03842, K03841, K03840, K03839, K03838, K03837, K03836, K03835, K03834, K03833, K03832, K03831, K03830, K03829, K03828, K03827, K03826, K03825, K03824, K03823, K03822, K03821, K03820, K03819, K03818, K03817, K03816, K03815, K03814, K03813, K03812, K03811, K03810, K03809, K03808, K03807, K03806, K03805, K03804, K03803, K03802, K03801, K03800, K03799, K03798, K03797, K03796, K03795, K03794, K03793, K03792, K03791, K03790, K03789, K03788, K03787, K03786, K03785, K03784, K03783, K03782, K03781, K03780, K03779, K03778, K03777, K03776, K03775, K03774, K03773, K03772, K03771, K03770, K03769, K03768, K03767, K03766, K03765, K03764, K03763, K03762, K03761, K03760, K03759, K03758, K03757, K03756, K03755, K03754, K03753, K03752, K03751, K03750, K03749, K03748, K03747, K03746, K03745, K03744, K03743, K03742, K03741, K03740, K03739, K03738, K03737, K03736, K03735, K03734, K03733, K03732, K03731, K03730, K03729, K03728, K03727, K03726, K03725, K03724, K03723, K03722, K03721, K03720, K03719, K03718, K03717, K03716, K03715, K03714, K03713, K03712, K03711, K03710, K03709, K03708, K03707, K03706, K03705, K03704, K03703, K03702, K03701, K03700, K03699, K03698, K03697, K03696, K03695, K03694, K03693, K03692, K03691, K03690, K03689, K03688, K03687, K03686, K03685, K03684, K03683, K03682, K03681, K03680, K03679, K03678, K03677, K03676, K03675, K03674, K03673, K03672, K03671, K03670, K03669, K03668, K03667, K03666, K03665, K03664, K03663, K03662, K03661, K03660, K03659, K03658, K03657, K03656, K03655, K03654, K03653, K03652, K03651, K03650, K03649, K03648, K03647, K03646, K03645, K03644, K03643, K03642, K03641, K03640, K03639, K03638, K03637, K03636, K03635, K03634, K03633, K03632, K03631, K03630, K03629, K03628, K03627, K03626, K03625, K03624, K03623, K03622, K03621, K03620, K03619, K03618, K03617, K03616, K03615, K03614, K03613, K03612, K03611, K03610, K03609, K03608, K03607, K03606, K03605, K03604, K03603, K03602, K03601, K03600, K03599, K03598, K03597, K03596, K03595, K03594, K03593, K03592, K03591, K03590, K03589, K03588, K03587, K03586, K03585, K03584, K03583, K03582, K03581, K03580, K03579, K03578, K03577, K03576, K03575, K03574, K03573, K03572, K03571, K03570, K03569, K03568, K03567, K03566, K03565, K03564, K03563, K03562, K03561, K03560, K03559, K03558, K03557, K03556, K03555, K03554, K03553, K03552, K03551, K03550, K03549, K03548, K03547, K03546, K03545, K03544, K03543, K03542, K03541, K03540, K03539, K03538, K03537, K03536, K03535, K03534, K03533, K03532, K03531, K03530, K03529, K03528, K03527, K03526, K03525, K03524, K03523, K03522, K03521, K03520, K03519, K03518, K03517, K03516, K03515, K03514, K03513, K03512, K03511, K03510, K03509, K03508, K03507, K03506, K03505, K03504, K03503, K03502, K03501, K03500, K03499, K03498, K03497, K03496, K03495, K03494, K03493, K03492, K03491, K03490, K03489, K03488, K03487, K03486, K03485, K03484, K03483, K03482, K03481, K03480, K03479, K03478, K03477, K03476, K03475, K03474, K03473, K03472, K03471, K03470, K03469, K03468, K03467, K03466, K03465, K03464, K03463, K03462, K03461, K03460, K03459, K03458, K03457, K03456, K03455, K03454, K03453, K03452, K03451, K03450, K03449, K03448, K03447, K03446, K03445, K03444, K03443, K03442, K03441, K03440, K03439, K03438, K03437, K03436, K03435, K03434, K03433, K03432, K03431, K03430, K03429
Risk classification: Class II
Area (FDA): device
Country: United States

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card