Olympic Cool-Cap System is intended to provide recall
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full…
Why was Olympic Cool-Cap System is intended to provide 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full…
- Recalling firm
- Natus Medical Incorporated
- Quantity
- 181 units
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA. and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; Kuwait; Poland; Russia; Saudi Arabia; Singapore; Slovenia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; United Arab Emirates; and United Kingdom.
- Recall date
- June 27, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)