PandaRecalls & reported problems across all models
Datex-Ohmeda, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Panda model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Panda by Datex-Ohmeda, Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2019 and Sep 28, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Break” (20 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Panda recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 9, 2024Open, 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 Panda problems
Device problems
- Break20
- Material Integrity Problem13
- Insufficient Flow or Under Infusion5
- No Flow5
- Detachment of Device or Device Component2
- Crack1
- Device Damaged Prior to Use1
- Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Patient Involvement13
Panda models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Panda i-Res Warmer 1.0WARMER, INFANT RADIANT1 recall15 reports
- Panda iRes WarmerWARMER, INFANT RADIANT34 reports
Recent Panda adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 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 50914350 ↗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 21, 2026Break
It was reported that there was a side panel was broken. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838640 ↗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 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691926 ↗MalfunctionSep 1, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543055 ↗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 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SIDE PANEL LATCH WAS DAMAGED / BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134826 ↗MalfunctionApr 7, 2026No Flow
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 24808805 ↗MalfunctionMar 25, 2026No Flow
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 24687682 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE SIDE RAIL DETACHED FROM THE BED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661626 ↗MalfunctionMar 20, 2026Crack
IT WAS REPORTED THAT THE WEST PANEL WAS BROKEN IN HALF. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649452 ↗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 ↗
Other Datex-Ohmeda, Inc. products
All Datex-Ohmeda, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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