Natus Olympic Cool-Cap System Recalled Due to Power Supply Failure
Natus Medical is recalling 181 Olympic Cool-Cap Systems because the power supply may fail without warning, interrupting cooling treatment for infants.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (interruption of critical medical treatment) where specific injury reports are not detailed in the source text.
Plain-English summary
Natus Medical Incorporated is recalling 181 units of the Olympic Cool-Cap System. This medical device is used to treat neonatal hypoxic-ischemic encephalopathy (HIE) in full-term infants by providing selective head cooling. The recall is due to a defect in the cooling module's power supply.
The power supply failure can occur without prior indication, resulting in the unavailability of the system to begin or continue cooling treatment. This interruption could prevent the device from providing the necessary 72 hours of monitored cooling for affected infants.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities and consumers should check the cooling serial numbers of their devices against the list provided in the official recall notice to determine if they are affected.
The recalled product
- Product
- Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides sel
- Manufacturer
- Natus Medical Incorporated
- Affected units
- 181
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Cooling Serial Numbers: 1008
- 1009
- 1011
- 1012
- 1014
- 1016
- 1017
- 1018
- 1020
- 1021
- 1022
- 1023
- 1024
- 1025
- 1027
- 1028
- 1030
- 1031
- 1034
- 1035
Distribution
Related recalls
Same manufacturer · Natus Medical Incorporated
See all →- HighExternal Drainage System Collection Bags Recalled for Sterility Assurance Issues
FDA (Devices) · 2024-01-10
- HighEDS 3 CSF External Drainage System recalled for incomplete sterility testing
FDA (Devices) · 2024-01-10
- HighNatus Cranial Access Kit Recalled Due to Defective Sterile Surgical Drapes
FDA (Devices) · 2022-12-28
- ModerateNatus Medical Recalls Olympic Pasteurmatic 3000 and 3500 Disinfection Systems
FDA (Devices) · 2017-07-19
- HighNatus Medical Recalls neoBLUE 2 Phototherapy Lights for Intensity Defect
FDA (Devices) · 2017-05-10
Same hazard · power supply failure
See all →- HighGalaxy System bronchoscope power supply defect may injure lung tissue
FDA (Devices) · 2025-01-01
- HighBD FACSLyric Flow Cytometer Power Supply May Fail During Use
FDA (Devices) · 2025-01-01
- HighMedical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
FDA (Devices) · 2025-01-01
- HighPhilips Patient Information Center iX UPS devices recalled for potential power failure
FDA (Devices) · 2024-05-01
- ModeratePrucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability
FDA (Devices) · 2023-09-27