Events

Rappel de Device Recall Aquatec Ocean VIP

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Invacare Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66461
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0167-2014
  • Date de mise en oeuvre de l'événement
    2013-08-31
  • Date de publication de l'événement
    2013-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122434
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Lift, patient, non-ac-powered - Product Code INN
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including PA and Internationally to Canada.
  • Description du dispositif
    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
  • Adresse du fabricant
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA