Agency classClass IOur severity:Severe FDA (Devices)·Z-0447-2013·Announced 2012-12-12

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock…"

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.…
Manufacturer: Natus Medical Incorporated
Category: Medical Device — Neonatal Cooling
Hazard: device-malfunction
treatment-interruption
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

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Same manufacturer · Natus Medical Incorporated

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