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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0618-2014

S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.

Publicado el 8 de enero de 2014 · Inicio del retiro: 26 de noviembre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Stryker Medical Division of Stryker Corporation
Distribuidor
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.
Lote
Models: 3002 S3 EX, 3002 S3 PATRIOT, 3002 S3 CUSTOM, 3002 S3 ZOOM, and 3002 S3 SIGNATURE. And Serial Numbers:080615942, 080715062, 080916706, 080916707, 080916708, 080916709, 080916710, 080916711, 080916712, 080916713, 080916714, 080916715, 080916716, 080916717, 090415690, 100215206, 100215207, 100215208, 100215209, 100215210, 100215211, 100215212, 100215213, 100215214, 100215215, 100215216, 100215217, 100215218, 100215219, 100215220, 100215221, 100215222, 100215223, 100215224, 100215225, 100215804, 100215805, 100215806, 100215807, 100215808, 100215809, 100215810, 100315078, 100315079, 100315080, 100315081, 100315082, 100315083, 100315084, 100315085, 100315086, 100315087, 100315088, 100315089, 100315090, 100315091, 100315092, 100315670, 100315671, 100315672, 100315673, 100315674, 100315675, 100315676, 100315677, 100315678, 100315679, 080815116, 091215376, 091215377, 091215378, 110215808, 110215809, 100815273, 100815274, 100815275, 100815276, 100815277, 100815278, 100815279, 100815280, 100815281, 100815282, 100815283, 100815284, 100815285, 100815286, 100815287, 100815288, 100815289, 100815290, 100815291, 100815292, 100815293, 100815294, 100815295, 101116017, 110215554, 100815726, 100815727, 100815728, 100815729, 100815730, 100815731, 100815732, 100815733, 100815734, 100815735, 100815736, 100815737, 100815738, 100815739, 100815740, 100815741, 100815742, 100815743, 100815744, 100815745, 100815746, 100815747, 100815748, 100815749, 100815750, 100815751, 100815752, 100815753, 100815754, 100815755, 100815756, 100815757, 100815758, 100815759, 100815760, 100815761, 100815884, 100815885, 100815886, 100815887, 100815888, 100815889, 100815890, 100815891, 100815892, 100815893, 100815894, 100815895, 100815896, 100815897, 100815898, 100815899, 100815900, 100815901, 100815902, 100815903, 100815904, 100815905, 100815906, 100815907, 100815908, 100815909, 100815910, 100815911, 100815912, 100815913, 100815914, 100815915, 100815916, 100815917, 100815918, 080815227, 090616274, 090616275, 090616276, 090616277, 090616278, 090616279, 080715001, 080715002, 080715003, 080715004, 080715005, 080715006, 080715007, 080715008, 080715009, 080715010, 080715011, 080715012, 080715013, 080715014, 080715015, 080715016, 080715017, 080715018, 080715019, 080715020, 080715021, 080715022, 080715023, 080715024, 080715025, 080715026, 080715027, 080715028, 080715029, 080715030, 080715031, 080715081, 080715082, 080715083, 080715084, 080715085, 080715086, 080715087, 080715088, 080715089, 080715090, 080715091, 080715092, 080715093, 080715094, 080715095, 080715096, 080715097, 080715098, 080715099, 080715100, 080715101, 080715102, 080715103, 080715104, 080715105, 080715106, 080715107, 080715108, 080715109, 080715110, 080715111, 080715114, 081215107, 090316108, 090415132, 090815025, 090815026, 090815027, 090815028, 090815029, 090815030, 090815031, 090815032, 090815033, 090815034, 090815035, 090815036, 090815037, 090815038, 090815039, 090815040, 090815041, 090815042, 090815043, 091116010, 091116011, 091116012, 091116013, 091116014, 091116015, 091116016, 091116017, 091116018, 091116019, 091116020, 091116021, 091116022, 091116023, 091116024, 091116025, 091116026, 091116027, 091116028, 091116029, 091116030, 091116031, 091116032, 091116033, 091116034, 091116035, 091116036, 091116037, 091116038, 091116039, 091116040, 100315027, 100315352, 100416123, 100515548, 100615297, 100615298, 100615300, 100615592, 100615696, 100615699, 100615700, 100615718, 100615829, 100616115, 100815876, 100815878, 100816127, 101015652, 101015653, 101015675, 101015677, 101015679, 101015955, 101015957, 101015958, 101015961, 101015962, 101016094, 101016097, 101016099, 101016100, 101016103, 10
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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