Events

Retiro De Equipo (Recall) de Device Recall Giraffe Omnibed and Incubator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64189
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1051-2013
  • Fecha de inicio del evento
    2013-01-08
  • Fecha de publicación del evento
    2013-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115522
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Incubator, neonatal - Product Code FMZ
  • Causa
    Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter, dated January 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were given the safety issue and instructions for continued use of the Giraffe OmniBed and Incubators, as well as given the affected product details. GE Healthcare will correct all affected Giraffe Incubators and Giraffe OmniBeds at no cost, and will contact customers to arrange for this correction. If customers have any questions or concerns regarding this notification, please call: United States: 1-800-345-2700. For other countries, please contact your local GE Healthcare Service Representative.

Device

Device Recall Giraffe Omnibed and Incubator
  • Modelo / Serial
    OmniBed Serial Numbers: HDGR52546, HDGR52736, HDGR52802, HDGR52861, HDGR52910, HDGR52958, HDGR53007, HDGR53058, HDGR53110, HDGR53185, HDGR52547, HDGR52737, HDGR52803, HDGR52862, HDGR52911, HDGR52959, HDGR53008, HDGR53059, HDGR53112, HDGR53186, HDGR52558, HDGR52739, HDGR52804, HDGR52863, HDGR52912, HDGR52960, HDGR53009, HDGR53060, HDGR53113, HDGR53187, HDGR52609, HDGR52740, HDGR52805, HDGR52864, HDGR52913, HDGR52961, HDGR53010, HDGR53061, HDGR53114, HDGR53188, HDGR52610, HDGR52741, HDGR52806, HDGR52865, HDGR52914, HDGR52962, HDGR53011, HDGR53062, HDGR53115, HDGR53189, HDGR52613, HDGR52742, HDGR52813, HDGR52866, HDGR52915, HDGR52963, HDGR53012, HDGR53063, HDGR53116, HDGR53190, HDGR52620, HDGR52743, HDGR52814, HDGR52867, HDGR52916, HDGR52964, HDGR53013, HDGR53064, HDGR53117, HDGR53191, HDGR52621, HDGR52744, HDGR52815, HDGR52868, HDGR52917, HDGR52965, HDGR53014, HDGR53065, HDGR53119, HDGR53192, HDGR52622, HDGR52745, HDGR52816, HDGR52869, HDGR52918, HDGR52966, HDGR53015, HDGR53066, HDGR53120, HDGR53193, HDGR52623, HDGR52746, HDGR52817, HDGR52870, HDGR52919, HDGR52967, HDGR53016, HDGR53067, HDGR53125, HDGR53194, HDGR52624, HDGR52747, HDGR52818, HDGR52871, HDGR52920, HDGR52968, HDGR53018, HDGR53068, HDGR53126, HDGR53195, HDGR52626, HDGR52748, HDGR52820, HDGR52872, HDGR52921, HDGR52969, HDGR53019, HDGR53069, HDGR53127, HDGR53196, HDGR52657, HDGR52749, HDGR52821, HDGR52873, HDGR52922, HDGR52970, HDGR53021, HDGR53070, HDGR53128, HDGR53197, HDGR52658, HDGR52750, HDGR52822, HDGR52874, HDGR52923, HDGR52971, HDGR53022, HDGR53071, HDGR53129, HDGR53213, HDGR52664, HDGR52751, HDGR52823, HDGR52875, HDGR52924, HDGR52972, HDGR53023, HDGR53072, HDGR53134, HDGR53214, HDGR52665, HDGR52752, HDGR52824, HDGR52876, HDGR52925, HDGR52973, HDGR53024, HDGR53073, HDGR53135, HDGR53215, HDGR52668, HDGR52753, HDGR52825, HDGR52877, HDGR52926, HDGR52974, HDGR53025, HDGR53074, HDGR53136, HDHR53216, HDGR52669, HDGR52754, HDGR52827, HDGR52878, HDGR52927, HDGR52975, HDGR53026, HDGR53075, HDGR53137, HDGR53217, HDGR52670, HDGR52755, HDGR52828, HDGR52879, HDGR52928, HDGR52976, HDGR53027, HDGR53076, HDGR53138, HDGR53219, HDGR52671, HDGR52756, HDGR52829, HDGR52880, HDGR52929, HDGR52977, HDGR53028, HDGR53077, HDGR53139, HDGR53220, HDGR52672, HDGR52757, HDGR52830, HDGR52881, HDGR52930, HDGR52978, HDGR53029, HDGR53078, HDGR53140, HDGR53221, HDGR52673, HDGR52758, HDGR52831, HDGR52882, HDGR52931, HDGR52979, HDGR53030, HDGR53079, HDGR53141, HDGR53222, HDGR52674, HDGR52759, HDGR52832, HDGR52883, HDGR52932, HDGR52980, HDGR53031, HDGR53080, HDGR53142, HDGR53223, HDGR52675, HDGR52760, HDGR52833, HDGR52884, HDGR52933, HDGR52981, HDGR53032, HDGR53081, HDGR53145, HDGR53224, HDGR52678, HDGR52761, HDGR52835, HDGR52885, HDGR52934, HDGR52982, HDGR53033, HDGR53085, HDGR53146, HDGR53225, HDGR52682, HDGR52762, HDGR52836, HDGR52886, HDGR52935, HDGR52983, HDGR53034, HDGR53086, HDGR53147, HDGR53226, HDGR52683, HDGR52763, HDGR52839, HDGR52887, HDGR52936, HDGR52984, HDGR53035, HDGR53087, HDGR53152, HDGR53231, HDGR52684, HDGR52764, HDGR52840, HDGR52888, HDGR52937, HDGR52985, HDGR53036, HDGR53088, HDGR53153, HDGR53232, HDGR52685, HDGR52765, HDGR52841, HDGR52890, HDGR52938, HDGR52986, HDGR53037, HDGR53089, HDGR53154, HDGR53235, HDGR52686, HDGR52768, HDGR52842, HDGR52891, HDGR52939, HDGR52987, HDGR53038, HDGR53090, HDGR53155, HDGR53241, HDGR52687, HDGR52769, HDGR52843, HDGR52892, HDGR52940, HDGR52988, HDGR53039, HDGR53091, HDGR53156, HDGR53242, HDGR52700, HDGR52770, HDGR52844, HDGR52893, HDGR52941, HDGR52990, HDGR53040, HDGR53092, HDGR53157, HDGR53251, HDGR52709, HDGR52771, HDGR52845, HDGR52894, HDGR52942, HDGR52991, HDGR53041, HDGR53093, HDGR53158, HDGR52714, HDGR52775, HDGR52846, HDGR52895, HDGR52943, HDGR52992, HDGR53042, HDGR53094, HDGR53159, HDGR52718, HDGR52776, HDGR52847, HDGR52896, HDGR52944, HDGR52993, HDGR53043, HDGR53095, HDGR53160, HDGR52720, HDGR52777, HDGR52848, HDGR52897, HDGR52945, HDGR52994, HDGR53044, HDGR53096, HDGR53161, HDGR52721, HDGR52778, HDGR52849, HDGR52898, HDGR52946, HDGR52995, HDGR53045, HDGR53097, HDGR53162, HDGR52723, HDGR52779, HDGR52850, HDGR52899, HDGR52947, HDGR52996, HDGR53047, HDGR53098, HDGR53163, HDGR52726, HDGR52780, HDGR52851, HDGR52900, HDGR52948, HDGR52997, HDGR53048, HDGR53099, HDGR53164, HDGR52727, HDGR52781, HDGR52852, HDGR52901, HDGR52949, HDGR52998, HDHR53049, HDGR53100, HDGR53165, HDGR52728, HDGR52782, HDGR52853, HDGR52902, HDHR52950, HDGR52999, HDGR53050, HDGR53102, HDGR53166, HDGR52729, HDGR52789, HDGR52854, HDGR52903, HDGR52951, HDGR53000, HDGR53051, HDGR53103, HDGR53167, HDGR52730, HDGR52790, HDGR52855, HDGR52904, HDGR52952, HDGR53001, HDGR53052, HDGR53104, HDGR53168, HDGR52731, HDGR52791, HDGR52856, HDGR52905, HDGR52953, HDGR53002, HDGR53053, HDGR53105, HDGR53169, HDGR52732, HDGR52792, HDGR52857, HDGR52906, HDGR52954, HDGR53003, HDGR53054, HDGR53106, HDGR53171, HDGR52733, HDGR52793, HDGR52858, HDGR52907, HDGR52955, HDGR53004, HDGR53055, HDGR53107, HDGR53175, HDGR52734, HDGR52794, HDGR52859, HDGR52908, HDGR52956, HDGR53005, HDGR53056, HDGR53108, HDGR53176, HDGR52735, HDGR52799, HDGR52860, HDGR52909, HDGR52957, HDGR53006, HDGR53057, HDGR53109, and HDGR53181. ***Incubator Serial Numbers: HDHR52549, HDHR52708, HDHR52774, HDHR52881, HDHR53029, HDHR52551, HDHR52709, HDHR52830, HDHR52882, HDHR53030, HDHR52552, HDHR52710, HDHR52831, HDHR52883, HDHR53031, HDHR52553, HDHR52711, HDHR52832, HDHR52884, HDHR53032, HDHR52554, HDHR52720, HDHR52833, HDHR52885, HDHR53039, HDHR52555, HDHR52721, HDHR52834, HDHR52894, HDHR53040, HDHR52556, HDHR52722, HDHR52835, HDHR52900, HDHR53041, HDHR52557, HDHR52723, HDHR52836, HDHR52901, HDHR53042, HDHR52559, HDHR52724, HDHR52837, HDHR52902, HDHR53043, HDHR52561, HDHR52725, HDHR52838, HDHR52903, HDHR53044, HDHR52562, HDHR52726, HDHR52839, HDHR52904, HDHR53045, HDHR52563, HDHR52727, HDHR52840, HDHR52905, HDHR53046, HDHR52564, HDHR52728, HDHR52841, HDHR52906, HDHR53047, HDHR52565, HDHR52729, HDHR52842, HDHR52907, HDHR53048, HDHR52567, HDHR52730, HDHR52843, HDHR52908, HDHR53049, HDHR52568, HDHR52731, HDHR52844, HDHR52909, HDHR53030, HDHR52569, HDHR52732, HDHR52845, HDHR52951, HDHR52910, HDHR52572, HDHR52733, HDHR52847, HDHR52911, HDHR53052, HDHR52573, HDHR52734, HDHR52848, HDHR52912, HDHR53053, HDHR52575, HDHR52735, HDHR52849, HDHR52913, HDHR53054, HDHR52576, HDHR52736, HDHR52850, HDHR52914, HDHR53055, HDHR52577, HDHR52737, HDHR52851, HDHR52915, HDHR53059, HDHR52578, HDHR52738, HDHR52852, HDHR52926, HDHR53062, HDHR52579, HDHR52739, HDHR52853, HDHR52927, HDHR52580, HDHR52740, HDHR52854, HDHR52928, HDHR52581, HDHR52741, HDHR52855, HDHR52929, HDHR52588, HDHR52742, HDHR52857, HDHR52971, HDHR52589, HDHR52743, HDHR52858, HDHR52972, HDHR52650, HDHR52744, HDHR52859, HDHR52974, HDHR52653, HDHR52745, HDHR52860, HDHR52975, HDHR52654, HDHR52746, HDHR52861, HDHR52976, HDHR52689, HDHR52747, HDHR52862, HDHR52977, HDHR52690, HDHR52748, HDHR52863, HDHR52978, HDHR52691, HDHR52749, HDHR52864, HDHR52979, HDHR52692, HDHR52750, HDHR52865, HDHR52981, HDHR52693, HDHR52751, HDHR52866, HDHR52982, HDHR52694, HDHR52752, HDHR52867, HDHR52983, HDHR52695, HDHR52753, HDHR52868, HDHR52985, HDHR52696, HDHR52754, HDHR52869, HDHR52986, HDHR52697, HDHR52759, HDHR52870, HDHR52987, HDHR52698, HDHR52760, HDHR52871, HDHR52988, HDHR52699, HDHR52767, HDHR52872, HDHR52989, HDHR52700, HDHR52768, HDHR52873, HDHR52990, HDHR52701, HDHR52769, HDHR52874, HDHR52991, HDHR52702, HDHR52770, HDHR52875, HDHR52992, HDHR52703, HDHR52771, HDHR52876, HDHR52993, HDHR52704, HDHR52772, HDHR52877, HDHR52994, HDHR52707, HDHR52773, HDHR52880, and HDHR52995.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA in the states of AR ,CA, CO, DC, FL, GA, HI, ID, IL, IN, KS, MA, MD, MI, MO, MS, NC, NE, NJ, NY, NV, OH, PA, TN, TX, VA, WA, WI, and WV, and the countries of Arab Emirates, Albania, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech., Denmark, Ecuador, Estonia, Finland, France, Germany, Hungary, Italy ,Korea, Kurdistan, Lebanon, Macedonia, Malaysia, Mexico, Norway, Oman, Poland, Russia, San Salvador, Saudi Arabia, Singapore, South Africa, Sweden, Turkey, Uruguay, Venezuela, and United Kingdom.
  • Descripción del producto
    Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. || GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA