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***"
Class I - DangerousWhat Should You Do?
- Check if you have this product: Cooling Serial Numbers: 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1030; 1031; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1080; 1081; 1082; 1083; 1085; 1086; 1087; 1088; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1101; 1116; 1117; 1118; 1119; 1120; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7013; 7014; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7265; 7266; 7267; 7268; 7269; 7270; 7271; 7272; 7273; 7274; 7275; 7276; 7277; 7278; 7279; 7280; 7281; 7282; 7283; 7284; 7285; 7286; 7288; 7289; 7290; 7291; 7292; 7293; 7294; 7363; 7364; 7365; 7366; 7372; and 7374.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Natus Medical Incorporated
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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***"
Product Codes/Lot Numbers:
Cooling Serial Numbers: 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1030; 1031; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1080; 1081; 1082; 1083; 1085; 1086; 1087; 1088; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1101; 1116; 1117; 1118; 1119; 1120; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7013; 7014; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7265; 7266; 7267; 7268; 7269; 7270; 7271; 7272; 7273; 7274; 7275; 7276; 7277; 7278; 7279; 7280; 7281; 7282; 7283; 7284; 7285; 7286; 7288; 7289; 7290; 7291; 7292; 7293; 7294; 7363; 7364; 7365; 7366; 7372; and 7374.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1843-2012
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