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Panda iRes Warmer

by Datex-Ohmeda Inc.

Ref M1112198

Panda iRes Warmer 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 11 May 2026 (Basic UDI-DI 8406821BUG00390HN), cleared under FDA 510(k) K201628 on 12 Feb 2021 (2 earlier submissions) and listed in FDA GUDID since 24 Jun 2016 (UDI-DI 00840682103893), active as of 9 Nov 2026. 16 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) K201628

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00390HN Basic UDI-DI 00840682103893UDI-DIDate11 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201628 Date12 Feb 2021DecidedStatusActive
United StatesGUDID listing GUDID Number00840682103893 UDI-DI Date24 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00390HN registered 11 May 2026 Active
  • FDA 510(k) K201628 decided 12 Feb 2021 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00840682103893 listed 24 Jun 2016 Listed

Recalls

17 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2358-2026 FDA Class I initiated 8 May 2026
    • Ongoing Z-2359-2026 FDA Class I initiated 8 May 2026

    Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

  • 2 recalls, same reason

    • Ongoing Z-3080-2024 FDA Class II initiated 9 Aug 2024
    • Ongoing Z-3081-2024 FDA Class II initiated 9 Aug 2024

    GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

  • 2 recalls, same reason

    • Terminated Z-1847-2019 FDA Class I initiated 15 Mar 2019
    • Terminated Z-1846-2019 FDA Class I initiated 15 Mar 2019

    The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.

  • 4 recalls, same reason

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

    Potential electric leakage affecting the user.

  • 4 recalls, same reason

    • Terminated Z-1549-2014 FDA Class II initiated 2 Apr 2014
    • Terminated Z-1550-2014 FDA Class II initiated 2 Apr 2014
    • Terminated Z-1547-2014 FDA Class II initiated 2 Apr 2014
    • Terminated Z-1548-2014 FDA Class II initiated 2 Apr 2014

    Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

  • 2 recalls, same reason

    • Terminated Z-0913-2014 FDA Class II initiated 12 Dec 2013
    • Terminated Z-0912-2014 FDA Class II initiated 12 Dec 2013

    Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

    • 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.

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

Timeline

22 dated events

  1. Recall initiated FDA recalls Z-0482-2019
  2. Recall initiated FDA recalls Z-0483-2019
  3. Recall initiated FDA recalls Z-1847-2019
  4. Recall initiated FDA recalls Z-1846-2019
  5. Cleared FDA 510(k) K201628
  6. Recall initiated FDA recalls Z-3080-2024
  7. Recall initiated FDA recalls Z-3081-2024
  8. Recall initiated FDA recalls Z-2358-2026
  9. Recall initiated FDA recalls Z-2359-2026
  10. Registered EUDAMED 8406821BUG00390HN

12 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
Panda iRes Warmer EUDAMED
Panda GUDID
Generic name
Infant warmer
Model / reference
M1112198 EUDAMED
iRes Warmer GUDID
Primary DI / UDI-DI
00840682103893
Basic UDI-DI
8406821BUG00390HN
Direct marketing DI
00840682152716
510(k) Number
FDA product code
FMT
EMDN code
Z12080407 Neonatal radiant warmers
GMDN term
Infant warmer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
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
M1112198
GUDID
iRes Warmer
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: Infant warmer

Cleared under the same submission (K101804)

Cleared under the same submission (K123309)

and 1 more cleared under K123309

Similar devices in this category

Other devices filed under NEONATAL RADIANT WARMERS.

Other devices from Datex-Ohmeda Inc.

See all devices from Datex-Ohmeda Inc. →

Properties

  • Administering medicine
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)