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Giraffe Shuttle

by Datex-Ohmeda Inc.

Ref 2094632-001

Giraffe Shuttle is a device classified as Class IIb in the EU and Class II in the US made by Datex-Ohmeda Inc., registered in EUDAMED on 18 May 2026 (Basic UDI-DI 8406821BUG00392HS), cleared under FDA 510(k) K101778 on 21 Jul 2010 (2 earlier submissions) and listed in FDA GUDID since 24 Jun 2016 (UDI-DI 00840682110808), active as of 23 Oct 2026. 13 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101778

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00392HS Basic UDI-DI 00840682110808UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682110808 UDI-DI Date24 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK101778 Date21 Jul 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00392HS registered 18 May 2026 Active
  • FDA 510(k) K101778 decided 21 Jul 2010 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00840682110808 listed 24 Jun 2016 Listed

Recalls

14 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2475-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2477-2026 FDA Class II initiated 1 May 2026

    GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

    • Ongoing Z-0047-2025 FDA Class I initiated 3 Sep 2024

    GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

    • Ongoing Z-2101-2023 FDA Class II initiated 19 May 2023

    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

  • 2 recalls, same reason

    • Terminated Z-2236-2020 FDA Class II initiated 28 Apr 2020
    • Terminated Z-2235-2020 FDA Class II initiated 28 Apr 2020

    Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

    • Terminated Z-2111-2020 FDA Class II initiated 2 Apr 2020

    During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.

    • Terminated Z-0538-2020 FDA Class I initiated 11 Oct 2019

    Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

  • 4 recalls, same reason

    • Terminated Z-0484-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0482-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0483-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0481-2019 FDA Class II initiated 25 Sep 2018

    Potential electric leakage affecting the user.

    • Terminated Z-1072-2014 FDA Class I initiated 1 Oct 2013 on shared 510(k) K101804

    Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

    • Terminated Z-1051-2013 FDA Class I initiated 8 Jan 2013

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-0481-2019
  2. Recall initiated FDA recalls Z-0538-2020
  3. Recall initiated FDA recalls Z-2111-2020
  4. Recall initiated FDA recalls Z-2236-2020
  5. Recall initiated FDA recalls Z-2235-2020
  6. Recall initiated FDA recalls Z-2101-2023
  7. Recall initiated FDA recalls Z-0047-2025
  8. Recall initiated FDA recalls Z-2475-2026
  9. Recall initiated FDA recalls Z-2477-2026
  10. Registered EUDAMED 8406821BUG00392HS

9 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Giraffe Shuttle EUDAMED
Giraffe GUDID
Generic name
Portable/mobile rechargeable battery pack
Model / reference
2094632-001 EUDAMED
Shuttle GUDID
Primary DI / UDI-DI
00840682110808
Basic UDI-DI
8406821BUG00392HS
Direct marketing DI
00840682110808
510(k) Number
FDA product code
FMZ, FMT
EMDN code
Z12080499 Neonatology instruments - other
GMDN term
Portable/mobile rechargeable battery pack
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
880.5400, 880.5130
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2094632-001
GUDID
Shuttle
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Portable/mobile rechargeable battery pack

Cleared under the same submission (K101804)

Similar devices in this category

Other devices filed under NEONATOLOGY INSTRUMENTS.

Other devices from Datex-Ohmeda Inc.

See all devices from Datex-Ohmeda Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)