Events

Device Recall Natus Medical Olympic CoolCap System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Natus Medical Incorporated 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61835
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0447-2013
  • 사례 시작날짜
    2012-05-09
  • 사례 출판 날짜
    2012-11-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109204
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Cap,cooling (infants) - Product Code MXM
  • 원인
    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.
  • 조치
    The firm, Natus Medical Incorporated, sent its customers an "URGENT: MEDICAL DEVICE" letter dated May 16, 2012 with an attached Field Safety Notice. The letter describes the product, problem and actions taken. Customers can call Natus Technical Service at 888-496-2887 for any questions about this recall.

Device

Device Recall Natus Medical Olympic CoolCap System
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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***"
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • 제조사 주소
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • 제조사 모회사 (2017)
    Natus Medical Incorporated
  • Source
    USFDA