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The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head c...

FDA Device Recall #Z-0447-2013 — Class I — May 9, 2012

Recall Summary

Recall Number Z-0447-2013
Classification Class I — Serious risk
Date Initiated May 9, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Natus Medical Incorporated
Location Seattle, WA
Product Type Devices
Quantity 324 units

Product Description

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. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in parts: "***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***"

Reason for Recall

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 displayed at the upper right hand corner of the screen stops advancing.

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AK, AR, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, KY, MA, MI, MN, MS, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, Puerto Rico, and countries of: Argentina, Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Ecuador, Egypt, Germany, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Kuwait, Latvia, Malaysia, Mexico, Morocco, Panama, Puerto Rico, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.

Lot / Code Information

1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1029; 1030; 1031; 1032; 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; 1079; 1080; 1081; 1082; 1083; 1084; 1085; 1086; 1087; 1088; 1089; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1098; 1101; 1116; 1117; 1118; 1119; 1120; 1121; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1134; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7012; 7013; 7014; 7015; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7029; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7050; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7254; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7266; 7268; 7269; 7274; 7276; 7277; 7281; 7286; 7287; 7289; 7293; 7305; 7306; 7307; 7308; 7310; 7311; 7327; 7330; 7348; 7351; 7356; 7358; 7360; 7363; 7364; 7365; 7366; 7367; 7368; 7369; 7370; 7371; 7372; 7374; 7375; 7376; 7377; 7378; 7380; 7381; 7383; 7384; 7385; 7386; 7387; 7388; 7389; 7394; 7400; 7401; 7402; 7405; 7406; 7407; 7409; 7410; 7411; 7412; 7413; 7414; 7416; 7418; 7420; 7421; 7424; 7431; 7433; 7434; 7435; 7436; 7437; 7438; 7440; 7441; 7265; 7267; 7270; 7271; 7272; 7273; 7275; 7278; 7279; 7280; 7282; 7283; 7284; 7285; 7288; 7290; 7291; 7292; 7294; 7295; 7296; 7297; 7298; 7299; 7300; 7301; 7302; 7303; 7304; 7309; 7312; 7313; 7314; 7315; 7316; 7317; 7318; 7319; 7320; 7321; 7322; 7323; 7324; 7325; 7326; 7328; 7329; 7331; 7332; 7333; 7334; 7335; 7336; 7337; 7338; 7339; 7340; 7341; 7342; 7343; 7344; 7345; 7346; 7347; 7349; 7350; 7352; 7353; 7354; 7355; 7357; 7359; 7361; 7362; 7379; 7382; 7391; 7392; 7393; 7395; 7397; 7398; 7399; 7403; 7404; 7408; 7422; 7423; 7429; 7432.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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