According to the latest press release from the FDA, Natus Medical has issued a “Class I Recall” for its Head Cooling Device, the Olympic Cool Cap System (Cool-Cap). The recall was initiated by the company after viewing the fact that the device’s Control Module may experience a frozen screen during treatment. When this occurs, the on-screen information remains on display, but the system is not providing cooling treatment to the infants.

The FDA has also said that the visible clock displayed at the upper right-hand corner of the screen may also stop displaying. The power supply failure can happen without prior indication and result in the unavailability of the system to begin or continue cooling treatment. This product failure may cause adverse health hazards and even death to a new born.

Meanwhile, the company has said that it is committed to offer better health-care services to people and is co-operating with the federal agency to fix the issue. The company has reiterated that it is coordinating the replacement of power supplies in all affected Olympic Cool-Cap Cooling Modules and will be contacting each of their customers to schedule the power supply replacement. For any pertaining query and issue customers can reach the Natus Technical Service at 1-888-496-2887.

What is Class I Recall?

Class I recalls are issued to drugs and medical devices for having some serious defects that could cause serious health problems to people and even death. Some of the examples where the federal agency could issue a class 1 recall include food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.

What is Olympic Cool Cap System?

The Olympic Cool Cap System (Cool-Cap) is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in full-term infants (at 36 weeks gestational age). A cooling water cap is placed on the infant’s head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The Cool-Cap is used with clinical evidence of moderate to severe HIE. The Cool-Cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.

About Natus

Natus is one of the leading providers of healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical ailments in newborn care, hearing impairment, epilepsy, sleep disorders, neurological dysfunction and many others.

Some of the products that the company has launched are:

  • Computerized neurodiagnostic systems for audiology, neurology, polysomnography, and neonatology, as well as newborn care products such as hearing screening systems,
  • Phototherapy devices for the treatment of newborn jaundice,
  • Head-cooling products for the treatment of brain injury in newborns, incubators to control the newborn’s environment, and software systems for managing and tracking disorders and diseases for public health laboratories.