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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92454

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 19, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DATEX--OHMEDA, INC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-2100-2023
Recall number
Z-2100-2023
Initiated
May 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
DATEX--OHMEDA, INC.
Quantity
4,540 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

Worldwide distribution.

device · product 2 of 3

Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal

Z-2101-2023
Recall number
Z-2101-2023
Initiated
May 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
DATEX--OHMEDA, INC.
Quantity
3,053 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All Lot/Serial Numbers

Distribution pattern

Worldwide distribution.

device · product 3 of 3

Beside panel FRU (Field Replacement Units) Kits

Z-2102-2023
Recall number
Z-2102-2023
Initiated
May 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
DATEX--OHMEDA, INC.
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34

Distribution pattern

Worldwide distribution.