Recall archive / FDA device enforcement
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, ... — FDA record Z-2100-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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
- Classification
- Class II
- Recalling firm
- DATEX--OHMEDA, INC.
- Quantity
- 4,540 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2100-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 12, 2023
- Recall initiation date
- May 19, 2023
- Center classification date
- Jul 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.