Natus Medical Incorporated: 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***"

Recall number

Z-1843-2012

Recalling firm

Natus Medical Incorporated

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 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***"

Status

Terminated

Initiated

2012-05-21

Posted

2012-06-20

Terminated

2014-02-21

Reason

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.

Root cause

Component design/selection

Action

Natus Medical Incorporated sent a URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTIONS Olympic Cool-Cap System letter dated May 21, 2012, to all affected customers. Fed-Ex to all U.S. customers, specifically to Biomedical department, NICU, with affected devices. The letter identified the product the problem and the action needed to be taken by the customer. In addition, Natus also sent the Urgent Field Safety Notice-Olympic Cool-Cap System (DOC-007459) dated May 2012 to all US customers and International Distribution Partners who were affected by both Frozen Screen and Power Supply field corrective action. Customers were instructed to: " During all routine checks of infants undergoing treatment, look at the clock displayed on the screen to verify that the seconds counter on the clock is advancing. The time displayed should continue to advance if the system is operating correctly. " If the system experiences a screen-freeze during a cooling session, the Olympic Cool-Cap system can be rebooted and cooling resumed. " Ensure that all the personnel in your facility that use the Olympic Cool-Cap system are advised of this Field Safety Notice (see attached). The U.S. customers are advised of the issue specifically stated in Action #2 in the letter and they are also informed that Natus will contact them within the next 30 to 120 days to schedule the power supply replacement in their affected system(s). Natus requires that the Distribution Partners to notify their customers with copies of the Natus recall letter and the Field Safety Notice (DOC-007459). Specifically these two documents should be addressed to both the Biomedical Department and the Neonatal Intensive Care Unit (NICU). Customers with questions about this recall should call Natus Technical Service at 888-496-2887 or email to TService@natus.com.

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P040025"]

Product code

MXM

Firm FEI

3018859

Firm city

Seattle

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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