Events

Device Recall Aquatec Ocean VIP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invacare Corporation 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
    66461
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0167-2014
  • 사례 시작날짜
    2013-08-31
  • 사례 출판 날짜
    2013-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122434
  • 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
    Lift, patient, non-ac-powered - Product Code INN
  • 원인
    The snap-on fixtures of the backrest cushion on the mobile shower and toilet commode aquatec ocean vip and ocean dual vip do not withstand a required pull out force of 500 n, when the product is used in a reclined position and or tilted position. this may result in the snap-on fixture coming unlatched.
  • 조치
    Invacare sent an Urgent Medical Device Recall Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge their receipt and understanding of the urgent recall notice and indicate the number of affected product in their inventory on the enclosed Provider Response Card. Customers were instructed to examine their existing stock and quarantine any affected product and fax the completed Provider Response Card immediately to Invacare Corporation at 440-326-3544. Customers were responsible for ensuring that the recall was conducted to the customer level. Correction kits were provided to the customers with the communication. Customers were instructed to document the correction details on the enclosed Product Tracking Sheet and fax to Invacare Customer Service at 440-326-3544. For questions regarding this recall call 440-329-3544.

Device

Device Recall Aquatec Ocean VIP
  • 모델명 / 제조번호(시리얼번호)
    The following model and serial numbers were affected by this recall:  Aquatec Ocean VIP Model number: 1470793 Serial numbers: 14541797; 14541800; 14541803; 14541804; 14541805; 14541806; 14541807; 14541808; 14541809; 14541810; 14541812; 14541820; 14541821; 14541822; 14541823; 14541825; 14541836; 14541837; 14541838; 14541839; 14541841; 14541842; 14541886; 14541918; 14541931; 14541937; 14541940; 14541941; 14541942; 14541944; 14541967; 14542408; 14542416; 14542418; 14542424; 14542435; 14542436; 14542437; 14542450; 14542451; 14542460; 14542462; 14542464; 14542468; 14542469; 14542472; 14542613; 14542614; 14542616; 14542652; 14542688; 14542689; 14542692; 14542693; 14542694; 14542695; 14542696; 14542700; 14542705; 14542712; 14542713; 14542714; 14542725; 14542734; 14542737; 14542738; 14542739; 14542750; 14542878; 14542879; 14542880; 14542885; 14542960; 14542967; 14542969; 14542970; 14543048; 14543050; 14543053; 14543055; 14543059; 14543064; 14543068; 14543077; 14543086; 14543087; 14543089; 14543090; 14543091; 14543092; 14543093; 14543094; 14543095; 14543096; 14543097; 14543101; 14543106; 14543107; 14543110; 14543111; 14543112; 14543113; 14543114; 14543115; 14543117; 14543118; 14543122; 14543124; 14543125; 14543126; 14543128; 14543129; 14543130; 14543131; 14543132; 14543133; 14543134; 14543136; 14543138; 14543139; 14543144; 14543147; 14543150; 14543151; 14543155; 14543156; 14543159; 14543160; 14543164; 14543165; 14543168; 14543171; 14543172; 14543173; 14543176; 14543177; 14543178; 14543180; 14543181; 14543182; 14543183; 14543185; 14543187; 14543191; 14543192; 14543193; 14543196; 14543199; 14545700; 14545701; 14545704; 14545706; 14545708; 14545709; 14545710; 14545711; 14545713; 14545715; 14545716; 14545717; 14545718; 14545719; 14545720; 14545721; 14545722; 14545723; 14545724;14545725; 14545727; 14545730; 14545731; 14545732; 14545733; 14545734; 14545735; 14545736; 14545737; 14545738; 14545739; 14545740; 14545741; 14545742; 14545743; 14545744; 14545745; 14545746; 14545747; 14546178; 14546179; 14546180; 14546181; 14546182; 14546183; 14546184; 14546185; 14546186; 14546187; 14546188; 14546189; 14546193; 14546194; 14546195; 14546198; 14546199; 14546200; 14546202; 14546203; 14546204; 14546205; 14546206; 14546207; 14546208; 14546209; 14546210; 14546212; 14546213; 14546216; 14546217; 14546233; 14546234; 14546238; 14546239; 14546240; 14546241; 14546255; 14546261; 14546262; 14546271; 14546314; 14546334; 14546336; 14546339; 14546340; 14546343; 14546345; 14546346; 14546349; 14546356; 14546366; 14546382; 14546383; 14546409; 14546410; 14546411; 14546415; 14546424; 14546431; 14546436; 14546438; 14546448; 14546450; 14546452; 14546453; 14546466; 14546468; 14546469; 14546470; 14546471; 14546472; 14546473; 14546474; 14546475; 14546476; 14546477; 14546478; 14546479; 14546480; 14546481; 14547312; 14546902; 14546903; 14546906; 14546911; 14546914; 14546917; 14546918; 14546920; 14546923; 14546930; 14546931; 14546939; 14546940; 14546942; 14546943; 14546944; 14546950; 14546952; 14546953; 14546954; 14546955; 14546956; 14546962; 14546964; 14546965; 14546968; 14546969; 14546970; 14546971; 14546972; 14546973; 14546974; 14546975; 14546976; 14546977; 14546978; 14546979; 14546980; 14546981; 14546982; 14546983; 14546984; 14546985; 14546986; 14546987; 14546988; 14546989; 14546990; 14546991; 14546992; 14546993; 14546994; 14546995; 14546996; 14547000; 14547003; 14547004; 14547006; 14547007; 14547008; 14547010; 14547012; 14547013; 14547015; 14547016; 14547019; 14547022; 14547027; 14547033; 14547034; 14547035; 14547224; 14547225; 14547227; 14547228; 14547230; 14547232; 14547235; 14547237; 14547239; 14547240; 14547242; 14547247; 14547249; 14547251; 14547253; 14547256; 14547259; 14547260; 14547261; 14547264; 14547266; 14547267; 14547271; 14547272; 14547273; 14547274; 14547283; 14547285; 14547286; 14547289; 14547291; 14547292; 14547293; 14547294; 14547295; 14547296; 14547300; 14547302; 14547309; 14547315; 14547317; 14547318; 14547324; 14547326; 14547332; 14547339; 14547340; 14547341; 14547345; 14547522; 14547523; 14547527; 14547538; 14547539; 14547540; 14547541; 14547543; 14547544; 14547545; 14547546; 14547553; 14547557; 14547558; 14547559; 14547560; 14547562; 14547563; 14547565; and 14547566.   Aquatec Ocean E-VIP Model number: 1471208 Serial numbers: 13A04000420; 13A04000421; 13A04005696; 13A04005697; 13A04005698; 13A04006199; and 13A04006200.   Aquatec Ocean Dual-VIP Model number: 1525707 Serial numbers: 14543203; 14543207; 14543209; 14543211; 14543213; 14543214; 14543215; 14543216; 14543217; 14543219; 14543225; 14543227; 14543231; 14543232; 14543233; 14543234; 14543235; 14543236; 14543237; 14543239; 14543240; 14543241; 14543242; 14543243; 14543244; 14543245; 14543246; 14543248; 14543249; 14543250; 14543251; 14543252; 14543255; 14543256; 14543266; 14543267; 14543268; 14543345; 14543346; 14543347; 14543348; 14543349; 14543350; 14543351; 14543352; 14543353; 14543354; 14543355; 14543356; 14543357; 14543358; 14543359; 14543360; 14543361; 14543362; 14543363; 14543364; 14543390; 14543392; 14543395; 14543402; 14543405; 14543457; 14543458; 14543459; 14543460; 14543461; 14543462; 14543463; 14543464; 14543465; 14543466; 14543467; 14543468; 14543469; 14543470; 14543471; 14543472; 14543473; 14543474; 14543475; 14543476; 14543523; 14543525; 14543526; 14543527; 14543528; 14543529; 14543530; 14543531; 14543532; 14543533; 14543534; 14543539; 14543540; 14543541; 14543542; 14543543; 14543544; 14543545; 14543547; 14543548; 14543596; 14543597; 14543598; 14543599; 14543600; 14543601; 14543602; 14543566; 14543571; 14543572; 14543573; 14543574; 14543575; 14543577; 14543578; 14543584; 14543585; 14543591; 14543592; and 14543595.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including PA and Internationally to Canada.
  • 제품 설명
    Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. || Mobile shower and toilet commode with tilting function
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • 제조사 주소
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • 제조사 모회사 (2017)
    Invacare Corporation
  • Source
    USFDA