Natus Olympic Cool-Cap Recalled Due to Frozen Screen Malfunction
Natus Medical is recalling 324 Olympic Cool-Cap systems because the control module screen may freeze, causing the device to stop cooling infants without visible alarm.
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 involves a medical device used on infants where a malfunction (frozen screen) results in the cessation of critical cooling treatment. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Natus Medical Incorporated is recalling 324 units of the Olympic Cool-Cap System, a selective head cooling device used to treat hypoxic-ischemic encephalopathy (HIE) in infants. The recall is due to a defect in the Control Module where the screen may freeze during use. When this occurs, the on-screen information remains visible, but the system stops providing cooling treatment to the infant. The visible clock in the upper right corner of the screen stops advancing, which may not be immediately obvious to users.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific part number for the recalled product is 60010.
Healthcare facilities should stop using the affected devices and contact Natus Medical Incorporated for instructions on repair or replacement. Consumers should not attempt to repair the device themselves.
The recalled product
- Product
- The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The
- Manufacturer
- Natus Medical Incorporated
- Affected units
- 324
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)
- 1008
- 1009
- 1011
- 1012
- 1014
- 1016
- 1017
- 1018
- 1020
- 1021
- 1022
- 1023
- 1024
- 1025
- 1027
- 1028
- 1029
- 1030
- 1031
- 1032
Distribution
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