Ventec Life Systems, Inc. Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001; Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
Brand
Ventec Life Systems, Inc.
Lot Codes / Batch Numbers
114304, 113728, 113729, 113697, 114296, 113587, 113684, 113706, 113003, 112957, 112961, 112962, 112965, 112972, 112974, 112994, 112995, 112999, 113006, 113008, 113010, 113520, 113522, 113525, 113533, 113534, 113536, 113547, 113550, 113555, 113556, 113557, 113561, 113563, 113689, 113724, 114021, 114101, 114105, 114106, 114107, 114109, 114110, 114111, 114116, 114117, 114310, 114333, 114108, 112792, 112798, 114497, 114324, 114325, 114330, 114336, 114493, 114537, 113046, 113662, 113667, 113682, 113591, 113594, 113654, 113655, 113740, 114020, 114030, 114044, 114046, 114048, 114096, 114114, 114019, 114025, 114027, 114033, 114039, 114040, 114045, 114051, 114028, 113704, 113746, 113748, 113753, 113760, 113061, 113725, 113586, 113691, 114307, 114309, 113028, 113066, 113539, 113515, 113709, 114047, 112814, 112824, 112829, 112830, 112844, 112848, 112865, 112866, 112807, 112822, 112823, 112834, 112835, 112847, 112854, 112876, 122848, 113758, 114508, 114951, 114342, 114343, 114346, 114351, 114360, 114500, 114345, 114499, 114505, 112976, 113037, 113040, 113524, 114322, 114498, 114510, 114636, 114640, 114641, 114676, 114685, 114695, 114701, 114820, 114827, 114841, 114900, 114901, 114674, 114725, 114800, 114810, 114812, 114822, 114825, 113057, 113063, 112821, 112839, 112842, 112867, 112826, 112837, 112825, 112982, 112987, 113510, 113511, 113546, 113584, 113592, 113652, 113686, 113710, 113723, 113756, 113671, 113675, 113715, 114009, 114013, 114489, 114494, 113549, 113744, 114637, 114947, 112765, 112766, 112767, 112768, 112770, 112774, 112775, 112776, 112778, 112779, 112780, 112787, 112815, 112841, 112862, 112968, 112977, 113013, 113014, 113016, 113017, 113018, 113027, 113032, 113039, 113050, 113535, 113562, 113588, 113658, 113755, 114032, 114488, 114842, AARC0001, AARC002, AARC003, AARC004, AARC005, AARC006, AARC007, AARC008, AARC009, 114095, 113590, 113598, 113233, 113238, 113239, 113241, 113243, 113244, 113245, 113603, 114193, 114201, 114255, 114266, 113405, 113906, 113962, 113407, 113414, 113430, 113390, 113437, 113262, 113380, 113458, 113384, 113398, 113442, 113858, 113441, 113443, 113445, 113915, 113817, 113898, 113899, 113378, 113395, 113923, 113972, 113937, 113945, 113957, 113961, 113968, 113368, 113373, 113379, 113264, 113351, 113389, 113370, 113377, 113454, 113468, 113804, 113823, 113830, 113837, 113838, 113881, 113882, 113888, 113892, 113902, 113927, 113967, 113399, Catalog Number: PRT-00900-100 GTIN (Primary ID): 00855573007785 Serial Numbers: 113096, 113300, 112923, 113107, 112877, 110392, 113143, 113183, 113274, 113323, Catalog Number: PRT-01098-000 GTIN (Primary ID): 00855573007730 Serial Numbers: 114444, 114451, 114615, 114226, 114442, 114450, 114452, 114441, 114453, Catalog Number: PRT-01100-000 GTIN (Primary ID): 00855573007747 Serial Numbers: 114556, 114591, 114634, 114771, 114779, 114603, 114606, 114667, 114710, 114713, 114737, 114739, 114559, 114783, 114869, 114576, 114587, 114364, 114369, 114374, 114387, 114391, 114560, 114568, 114764, 114776, 114787, 114849, 114549, 114569, 114705, 114562, 114355, 114372, 114405, 114550, 114594, 114601, 114652, 114659, 114661, 114662, 114358, 114383, 114386, 114389, 114390, 114530, 114540, 114401, 114422, 114424, 114548, 114670, 114714, 114850, 114414, 114417, 114554, 114561, 114861, 114862, 114543, 114786, 114789, 114912, 114917, 114851, 114628, 114211, 114542, 114528, 114531, 114483, 114750, 114643, 114644, 114748, 114926, 114991, 114891, 114892, 114894, 114357, 114409, 114604, 114413, 114653, 114654, 114734, 114754, Catalog Number: PRT-01100-001 GTIN (Primary ID): 00855573007747 Serial Numbers: 114965, 114966, 114967
Products Sold
Catalog Number: PRT-00490-001 GTIN (Primary ID): 00855573007792/00855573007006 Serial Numbers: 114303; 114304; 113728; 113729; 113697; 114296; 113587; 113684; 113706; 113003; 112957; 112961; 112962; 112965; 112972; 112974; 112994; 112995; 112999; 113006; 113008; 113010; 113520; 113522; 113525; 113533; 113534; 113536; 113547; 113550; 113555; 113556; 113557; 113561; 113563; 113689; 113724; 114021; 114101; 114105; 114106; 114107; 114109; 114110; 114111; 114116; 114117; 114310; 114333; 114108; 112792; 112798; 114497; 114324; 114325; 114330; 114336; 114493; 114537; 113046; 113662; 113667; 113682; 113591; 113594; 113654; 113655; 113740; 114020; 114030; 114044; 114046; 114048; 114096; 114114; 114019; 114025; 114027; 114033; 114039; 114040; 114045; 114051; 114028; 113704; 113746; 113748; 113753; 113760; 113061; 113725; 113586; 113691; 114307; 114309; 113028; 113066; 113539; 113515; 113709; 114047; 112814; 112824; 112829; 112830; 112844; 112848; 112865; 112866; 112807; 112822; 112823; 112834; 112835; 112847; 112854; 112876; 122848; 113758; 114508; 114951; 114342; 114343; 114346; 114351; 114360; 114500; 114345; 114499; 114505; 112976; 113037; 113040; 113524; 114322; 114498; 114510; 114636; 114640; 114641; 114676; 114685; 114695; 114701; 114820; 114827; 114841; 114900; 114901; 114674; 114725; 114800; 114810; 114812; 114822; 114825; 113057; 113063; 112821; 112839; 112842; 112867; 112826; 112837; 112825; 112982; 112987; 113510; 113511; 113546; 113584; 113592; 113652; 113686; 113710; 113723; 113756; 113671; 113675; 113715; 114009; 114013; 114489; 114494; 113549; 113744; 114637; 114947; 112765; 112766; 112767; 112768; 112770; 112774; 112775; 112776; 112778; 112779; 112780; 112787; 112815; 112841; 112862; 112968; 112977; 113013; 113014; 113016; 113017; 113018; 113027; 113032; 113039; 113050; 113535; 113562; 113588; 113658; 113755; 114032; 114488; 114842; AARC0001; AARC002; AARC003; AARC004; AARC005; AARC006; AARC007; AARC008; AARC009; 114095; 113590; Catalog Number: PRT-00490-100 GTIN (Primary ID): 00855573007761/00855573007204 Serial Numbers: 112929; 113598; 113233; 113238; 113239; 113241; 113243; 113244; 113245; 113603; 114193; 114201; 114255; 114266; Catalog Number: PRT-00900-001 GTIN (Primary ID): 00855573007778/00855573007433 Serial Numbers: 113365; 113405; 113906; 113962; 113407; 113414; 113430; 113390; 113437; 113262; 113380; 113458; 113384; 113398; 113442; 113858; 113441; 113443; 113445; 113915; 113817; 113898; 113899; 113378; 113395; 113923; 113972; 113937; 113945; 113957; 113961; 113968; 113368; 113373; 113379; 113264; 113351; 113389; 113370; 113377; 113454; 113468; 113804; 113823; 113830; 113837; 113838; 113881; 113882; 113888; 113892; 113902; 113927; 113967; 113399; Catalog Number: PRT-00900-100 GTIN (Primary ID): 00855573007785 Serial Numbers: 113096; 113300; 112923; 113107; 112877; 110392; 113143; 113183; 113274; 113323; Catalog Number: PRT-01098-000 GTIN (Primary ID): 00855573007730 Serial Numbers: 114444; 114451; 114615; 114226; 114442; 114450; 114452; 114441; 114453; Catalog Number: PRT-01100-000 GTIN (Primary ID): 00855573007747 Serial Numbers: 114556; 114591; 114634; 114771; 114779; 114603; 114606; 114667; 114710; 114713; 114737; 114739; 114559; 114783; 114869; 114576; 114587; 114364; 114369; 114374; 114387; 114391; 114560; 114568; 114764; 114776; 114787; 114849; 114549; 114569; 114705; 114562; 114355; 114372; 114405; 114550; 114594; 114601; 114652; 114659; 114661; 114662; 114358; 114383; 114386; 114389; 114390; 114530; 114540; 114401; 114422; 114424; 114548; 114670; 114714; 114850; 114414; 114417; 114554; 114561; 114861; 114862; 114543; 114786; 114789; 114912; 114917; 114851; 114628; 114211; 114542; 114528; 114531; 114483; 114750; 114643; 114644; 114748; 114926; 114991; 114891; 114892; 114894; 114357; 114409; 114604; 114413; 114653; 114654; 114734; 114754; Catalog Number: PRT-01100-001 GTIN (Primary ID): 00855573007747 Serial Numbers: 114965; 114966; 114967;
Ventec Life Systems, Inc. is recalling Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/Eng due to Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.
Recommended Action
Per FDA guidance
During the week of May 10, 2021, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter via FedEx or overnight mail to customers informing them that due to malfunctions of the Control Board there is the potential of unexpected shut downs and/or lost of ventilator blower function. As a result, the ventilators may fail to provide ventilation therapy to the patients. Customers are instructed to complete the following clinical action until a replacement unit can be provided: Follow your procedures to transfer the patient to an alternative source of ventilation, if available. If no other ventilation method is available, you may continue to use the affected product adhering to the guidelines below: 1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction. 2. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 3. Use an external SpO2 monitor and set the alarm thresholds appropriately if the patient is oxygen dependent. 4. Connect the ventilator to an external monitoring system, wherever possible. In addition, Customers are to acknowledge receipt of the Customer Notification Letter by: 1. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to Ventec within 7 days. 2. Upon receipt of the Customer Response Form, Ventec will arrange shipment of replacement device(s) or arrange repair of existing device(s). 3. Return the affected product to Ventec per instructions and shipping label provided with replacement device(s). Contact Ventec Customer Support at 844-MYVOCSN (844-698-6276) to discuss alternative arrangements, if necessary. If customers are no longer the owner of any of these devices, they need to complete an ownership transfer form at VentecLife.com/tracking so that the Recalling Firm can follow up with the current owner of the impacted device(s). If customers have any question
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026