DeRoyal VHNICU-37Recalls & reported problems
Deroyal Industries, Inc. · HYDRO-TEMP® · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756927574), received between Aug 7, 2024 and Jan 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem2
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hyperthermia1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Device Sensing Problem
A USER FACILITY REPORTED, "THE PROBES WERE READING THE WRONG TEMPERATURES AND OVERHEATING THE BABIES."
Patient problems: Hyperthermia
MAUDE report 24085005 ↗MalfunctionDec 16, 2025Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, "THE TEMPERATURE IS NOT READING PROPERLY AND IS NOT WORKING WELL WITH GE GIRAFFE BEDS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815385 ↗MalfunctionAug 7, 2024Overheating of Device; Overheating of Device
THE TEMPERATURE PROBES ARE OVERHEATING. THE ISOLETTES ARE OVERHEATING WHEN USING THE TEMPERATURE PROBES. THIS IS HAPPENING ON OLDER AND NEW MODEL ISOTLETTES. THEY HAVE EVEN SWITCHED OUT AN ISOLETTE 3 TIMES WITH A PATIENT TO SEE IF IT WAS A BED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931701 ↗
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- DeRoyal HNICU-37Deroyal Industries, Inc. · WARMER, INFANT RADIANT25 reports
- F&P Neopuff RD900AFUFisher & Paykel Healthcare Limited · Warmer, Infant Radiant18 reports
- DeRoyal HNICU-03Deroyal Industries, Inc. · WARMER, INFANT RADIANT5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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