Events

Recall of Device Recall Giraffe Omnibed and Incubator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64189
  • Event Risk Class
    Class 1
  • Event Number
    Z-1051-2013
  • Event Initiated Date
    2013-01-08
  • Event Date Posted
    2013-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115522
  • Notes / Alerts
    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.
  • Extra notes in the data
    Incubator, neonatal - Product Code FMZ
  • Reason
    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.
  • Action
    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
  • Model / 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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA