Class 1 Device Recall Giraffe Omnibed and Incubator

• Date Initiated by Firm: January 08, 2013
• Date Posted: April 05, 2013
• Recall Status: Terminated on July 10, 2013
• Recall Number: Z-1051-2013
• Recall Event ID: 64189
• 510(K)Number: K101778 K101788
• Product Classification: Incubator, neonatal - Product Code FMZ
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: James Giles; 262-513-4122
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 679 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMZ