Z-1051-2013Class I

Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880...

Name: Z-1051-2013 Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880...
Creator: GE Healthcare, LLC
Published: 2013-01-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-01-08 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of 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... on 2013-01-08. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1051-2013
Classification: Class I
Status: Terminated
Initiated: 2013-01-08
Posted: 2013-04-05
Terminated: 2013-07-10
Recalling firm: GE Healthcare
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.
Product code: FMZ Incubator, Neonatal
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1051-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1051-2013	Class I	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-05

Product code FMZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)