Giraffe and Panda Warmers

• • 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

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

  Potential electric leakage affecting the user.

• 4 recalls, same reason

  • 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
  • Terminated Z-1549-2014 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-0912-2014 FDA Class II ·initiated 12 Dec 2013
  • Terminated Z-0913-2014 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.

510(k) Number

K123309 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)

  Class II

  FDA 510(k) K072157 Active Cleared 27 Aug 2007

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  FDA 510(k) K993407 Active Cleared 5 Jan 2000

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  FDA 510(k) K960964 Active Cleared 27 Sep 1996

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  FDA 510(k) K993712 Active Cleared 9 Nov 1999

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  FDA 510(k) K871398 Active Cleared 7 May 1987

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  Class II

  FDA 510(k) K896023 Active Cleared 4 Jan 1990

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