# K123309: Giraffe and Panda Warmers

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Feb 5, 2013 after 104 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 13 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 25 ancestors in all.
No later device cites it as a predicate yet.
7 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122267: Giraffe and Panda Warmers, Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (2012) Summary page 1.
- K101804: Giraffe and Panda Warmers, Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (2010) Summary page 1.
- K090697: Modification to: Giraffe and Panda Warmer, Ohmeda Medical (2009) Summary page 2.
- K072157: Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply), Ohmeda Medical (2007) Summary page 1.
- K070377: Giraffe and Panda Warmer, Ohmeda Medical (2007) Summary page 1.

## Recalls of this device
- May 8, 2026 · Class I · Z-2359-2026: 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, poten
- Mar 15, 2019 · Class I · Z-1847-2019: 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 ha
- Mar 15, 2019 · Class I · Z-1846-2019: 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 ha
- Sep 25, 2018 · Class II · Z-0482-2019: Potential electric leakage affecting the user.
- Sep 25, 2018 · Class II · Z-0481-2019: Potential electric leakage affecting the user.
- Sep 25, 2018 · Class II · Z-0483-2019: Potential electric leakage affecting the user.
- Sep 25, 2018 · Class II · Z-0484-2019: Potential electric leakage affecting the user.
- Apr 2, 2014 · Class II · Z-1547-2014: 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.
- Apr 2, 2014 · Class II · Z-1550-2014: 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.
- Apr 2, 2014 · Class II · Z-1549-2014: 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.
- Apr 2, 2014 · Class II · Z-1548-2014: 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.
- Dec 12, 2013 · Class II · Z-0913-2014: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- Dec 12, 2013 · Class II · Z-0912-2014: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

## Indications for use
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SPO 2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp0z) and pulse rate (measured by an SPOZ sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

Source page: https://510kreport.com/device/K123309
Methodology: https://510kreport.com/methodology