Panda i-Res Warmer 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840682152709), received between Apr 21, 2025 and Sep 23, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 other recalls cover devices cleared under the same FDA submission (K070377, K090697, K122267, K123309); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 9, 2024Class IIOpen, Classified

   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.

   Z-3081-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that the side panel was damaged. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868693 ↗
• MalfunctionSep 18, 2026Insufficient Flow or Under Infusion

  It was reported that there was a malfunction during service causing loss of oxygen concentration. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817298 ↗
• MalfunctionJul 30, 2026Break

  It was reported that the front panel was broken. There was no patient involvement reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50082663 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558094 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT THE SIDEWALL PANEL LATCH WAS DAMAGED DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512251 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496213 ↗
• MalfunctionMar 3, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SIGNIFICANT DEGRADATION OR LOSS OF OXYGEN THERAPY DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496071 ↗
• MalfunctionFeb 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SIDE PANEL WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469021 ↗
• MalfunctionFeb 26, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455506 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A BROKEN SIDE PANEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936198 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN SIDE PANEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877048 ↗
• MalfunctionJul 2, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385458 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009225 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967652 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE FRONT PANEL WALL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871752 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070377, K090697, K122267, K123309. One submission often covers many models, so check the product and lot details in each record.

• Z-2359-2026 · May 8, 2026 · Open, Classified
  Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenanc
• Z-1847-2019 · Mar 15, 2019 · Terminated
  Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infa
• Z-1846-2019 · Mar 15, 2019 · Terminated
  Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. In
• Z-0484-2019 · Sep 25, 2018 · Terminated
  Panda Wall Mount warmer. Infant radiant warmer
• Z-0482-2019 · Sep 25, 2018 · Terminated
  Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
• Z-0481-2019 · Sep 25, 2018 · Terminated
  Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
• Z-0483-2019 · Sep 25, 2018 · Terminated
  Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
• Z-1508-2017 · Nov 18, 2016 · Terminated
  Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to therm
• Z-1506-2017 · Nov 18, 2016 · Terminated
  Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based
• Z-1547-2014 · Apr 2, 2014 · Terminated
  Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitorin
• Z-1550-2014 · Apr 2, 2014 · Terminated
  Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated
• Z-1549-2014 · Apr 2, 2014 · Terminated
  Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrat
• Z-1548-2014 · Apr 2, 2014 · Terminated
  Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monito
• Z-0912-2014 · Dec 12, 2013 · Terminated
  Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe Infant Warmers provide infrared h
• Z-0913-2014 · Dec 12, 2013 · Terminated
  Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehea

…and 2 more.