Events

Retiro De Equipo (Recall) de Device Recall Aquatec Ocean VIP

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Invacare Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66461
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0167-2014
  • Fecha de inicio del evento
    2013-08-31
  • Fecha de publicación del evento
    2013-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122434
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Lift, patient, non-ac-powered - Product Code INN
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including PA and Internationally to Canada.
  • Descripción del producto
    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
  • Dirección del fabricante
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Empresa matriz del fabricante (2017)
    Invacare Corporation
  • Source
    USFDA