Reported Jun 27, 2012 · Terminated
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The…
Natus Medical Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Natus Medical Incorporated · 5900 1st Ave S · Seattle, WA · 98108-3248
Is this the product you have?
- 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 selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal 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 Cool-Cap provides 72 hours of monitored cooling
- The device is labeled in part"***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"
- Lot codes and dates
- Cooling Serial Numbers
181 of 181 codes
100810091011101210141016101710181020102110221023102410251027102810301031103410351036103810441045104810501051105210531054105510561059106010621063106410651066107010711072107310741075107610771080108110821083108510861087108810901091109210931094
- Cooling Serial Numbers
- Amount recalled
- 181 units
Where it was sold
Why it was recalled
Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
This product could cause temporary or reversible health problems — stop using it.
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