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U.S. Department of Health and Human Services

Class 2 Device Recall Aquatec Ocean VIP

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  Class 2 Device Recall Aquatec Ocean VIP see related information
Date Initiated by Firm August 31, 2013
Date Posted November 05, 2013
Recall Status1 Terminated 3 on September 15, 2014
Recall Number Z-0167-2014
Recall Event ID 66461
Product Classification Lift, patient, non-ac-powered - Product Code INN
Product 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
Code Information 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.
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 538 (US only) 3317 (Total)
Distribution Worldwide Distribution - USA including PA and Internationally to Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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