Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, ASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make. Incubator, Neonatal, Warmer, Infant radiant
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
Issued by
FDA
Distribution: Worldwide distribution.
Lot/Code Info: a. Model Number 2082844-001-XXX; GTIN Numbers: 010084068211686221, 010084068211686221; All Lot/Serial Numbers. b. Model Number 2074920-001-XXXXXX; No GTIN Number; Serial Numbers: HDGR52137, HDGL50099, HDGT60164, HDGT60143, HDGT60142, HDGT60139, HDGT60138, HDGT60137, HDGU60753, HDGT60652, HDGU60069, HDGT60141, HDGU60156, HDGU60120, HDGU60119, HDGT60163, HDGT60703, HDGT60245, HDGT60160, HDGT60459, HDGT60246, HDGT60235, HDGU67645, HDGU60065, HDGU60063, HDGU60061, HDGU63122, HDGU63121, HDGU60062, HDGU57534, HDGU67533, HDGU67534, HDGT60460, HDGU67236, HDGT60249, HDGU60201, HDGU60570, HDGU60620, HDGU60023, HDGU60020, HDGT60612, HDGU60022, HDGU60571, HDGU60686, HDGU60202, HDGV60190, HDGW60244, HDGU67677, HDGU67676, HDGU67675, HDGU67280, HDGU67416, HDGU67415, HDGU67382, HDGU67377, HDGU67369, HDGU67366, HDGU67362, HDGU67289, HDGU67284, HDGU67282, HDGU63165, HDGU63167, HDGU63166, HDGV61084, HDGU67436, HDGU67423, HDGU67422, HDGU67421, HDGU67420, HDGU67419, HDGU67418, HDGU67414, HDGU67413, HDGU67381, HDGU67380, HDGU67379, HDGU67378, HDGU67370, HDGU67368, HDGU67367, HDGU67365, HDGU67363, HDGU67361, HDGU67360, HDGU67359, HDGU67358, HDGU67357, HDGU67304, HDGU67303, HDGU67302, HDGU67301, HDGU67300, HDGU67299, HDGU67298, HDGU67297, HDGU67296, HDGU67295, HDGU67294, HDGU67293, HDGU67292, HDGU67291, HDGU67290, HDGU67288, HDGU67287, HDGU67286, HDGU67285, HDGU67283, HDGU67281, HDGJ51159, HDGT60613, HDGT60614, HDGU60700, HDGU60703. c. Model Number M1050205; No GTIN Number; Serial Numbers: HDGV60148, HDGU60656, HDGU60658, HDGT60481, HDGS50047, HDGV60146. d. Model Number M1135822; No GTIN Number; Serial Numbers: HDGL51737, HDGL51738, HDGL51734, HDGM50736, HDGM50841, HDGL51735. e. Model Number M1145475; No GTIN Number; Serial Numbers: HDGM51813, HDGM52120, HDGM52119, HDGN50474, HDGN50472, HDGN50471, HDGN50469, HDGN50466, HDGN50464, HDGN50848, HDGN50847, HDGN50846, HDGN50845, HDGN50844, HDGQ50049, HDGR53203, HDGS51654, HDGS51653, HDGS51652, HDGS51651, HDGS51650, HDGS51649, HDGS51648, HDGS51647, HDGS51646, HDGS51645, HDGM51179, HDGQ50425, HDGN50465, HDGN50849, HDGN50467, HDGN50470, HDGN50475, HDGR52324, HDGR52323, HDGR52322, HDGR52321, HDGN50468. f. Model Number M1145476; No GTIN Number; Serial Numbers: HDGR52896. g. Model Number M1235957; No GTIN Number; Serial Numbers: HDGT60222. h. Model Number M1149051; No GTIN Number; Serial Numbers: HDGR53018, HDGR53085, HDGR52927, HDGR53086, HDGR53021. i. Model Number M1146098; No GTIN Number; Serial Numbers: HDGS52233, HDGS52234.
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.