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U.S. Department of Health and Human Services

Class 1 Device Recall Giraffe Omnibed and Incubator

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 Class 1 Recall
Giraffe Omnibed and Incubator
see related information
Date Posted April 05, 2013
Recall Status1 Terminated on July 10, 2013
Recall Number Z-1051-2013
Recall Event ID 64189
Premarket Notification
510(K) Numbers
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, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMZ and Original Applicant = OHMEDA MEDICAL
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