Class 2 Device Recall Invacare Pronto Air Personal Transporter (power wheelchair)

• Date Initiated by Firm: February 02, 2015
• Date Posted: August 10, 2015
• Recall Status: Terminated on September 14, 2015
• Recall Number: Z-2358-2015
• Recall Event ID: 71613
• 510(K)Number: K021680
• Product Classification: Wheelchair, powered - Product Code ITI
• Product: Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
• Code Information: Model #AIRPTMBDY18, Serial #s: 12JSZD60025, 12JSZD60026, 12JSZD60027, 12KSZD60001, 12KSZD60002, 12KSZD60004, 12KSZD60005, 12KSZD60006, 12KSZD60007, 12KSZD60008, 12KSZD60010, 12KSZD60013, 12KSZD60014, 12KSZD60015, 12KSZD60016, 12KSZD60017, 12KSZD60018, 12KSZD60019, 12KSZD60020, 12KSZD60021, 12KSZD60022, 12KSZD60023, 12KSZD60024, 12KSZD60026, 12KSZD60028, 12KSZD60029, 12KSZD60030, 12KSZD60031, 12KSZD60032, 12KSZD60033, 12KSZD60034, 12KSZD60035, 12KSZD60036, 12KSZD60037, 12KSZD60038, 12KSZD60039, 12KSZD60040, 12KSZD60041, 12KSZD60042, 12KSZD60043, 12KSZD60045, 12KSZD60046, 12KSZD60047, 12KSZD60048, 12KSZD60049, 12KSZD60050, 12KSZD60051, 12KSZD60052, 12KSZD60053, 12KSZD60054, 12KSZD60055, 12KSZD60056, 12KSZD60057, 12KSZD60058, 12KSZD60059, 12KSZD60060, 12KSZD60061, 12KSZD60063, 12KSZD60064, 12KSZD60065, 12KSZD60066, 12KSZD60067, 12KSZD60069, 12KSZD60070, 12KSZD60071, 12KSZD60072, 12KSZD60073, 12KSZD60075, 12KSZD60076, 12KSZD60077, 12KSZD60078, 12KSZD60079, 12KSZD60080, 12KSZD60081, 12KSZD60082, 12KSZD60083, 12KSZD60085, 12KSZD60086, 12KSZD60087, 12KSZD60088, 12KSZD60091, 12KSZD60092, 12KSZD60093, 12KSZD60094, 12KSZD60095, 12KSZD60096, 12KSZD60098, 12KSZD60099, 12KSZD60100, 12KSZD60101, 12KSZD60103, 12KSZD60105, 12KSZD60107, 12KSZD60108, 12KSZD60109, 12KSZD60110, 12KSZD60111, 12KSZD60112, 12KSZD60114, 12KSZD60115, 12KSZD60116, 12KSZD60117, 12KSZD60118, 12KSZD60120, 12KSZD60121, 12KSZD60122, 12KSZD60123, 12KSZD60124, 12KSZD60125, 12KSZD60126, 12KSZD60127, 12KSZD60128, 12KSZD60129, 12KSZD60130, 12KSZD60131, 12KSZD60134, 12KSZD60136, 12KSZD60137, 12KSZD60138, 12KSZD60139, 12KSZD60140, 12KSZD60141, 12KSZD60142, 12KSZD60143, 12KSZD60144, 12KSZD60145, 12KSZD60146, 12KSZD60147, 12KSZD60148, 12KSZD60149, 12KSZD60151, 12KSZD60152, 12KSZD60153, 12KSZD60154, 12KSZD60155, 12KSZD60156, 12KSZD60158, 12KSZD60159, 12KSZD60160, 12KSZD60162, 12KSZD60163, 12KSZD60164, 12KSZD60165, 12KSZD60166, 12KSZD60168, 12KSZD60169, 12KSZD60170, 12KSZD60171, 12KSZD60172, 12KSZD60173, 12KSZD60174, 12KSZD60176, 12KSZD60177, 12KSZD60178, 12KSZD60179, 12KSZD60180, 12KSZD60181, 12KSZD60182, 12KSZD60183, 12KSZD60186, 12KSZD60187, 12KSZD60188, 12KSZD60189, 12KSZD60190, 12KSZD60191, 12KSZD60192, 12KSZD60193, 12KSZD60194, 12KSZD60195, 12KSZD60197, 12KSZD60198, 12KSZD60199, 12KSZD60200, 12KSZD60201, 12KSZD60203, 12KSZD60204, 12KSZD60205, 12KSZD60206, 12KSZD60207, 12KSZD60209, 12KSZD60211, 12KSZD60212, 12KSZD60213, 12KSZD60214, 12KSZD60215, 12KSZD60216, 12KSZD60217, 12KSZD60219, 12KSZD60220, 12LSZD60001, 12LSZD60002, 12LSZD60003, 12LSZD60004, 12LSZD60006, 12LSZD60007, 12LSZD60008, 12LSZD60009, 12LSZD60011, 12LSZD60012, 12LSZD60014, 12LSZD60015, 12LSZD60017, 12LSZD60018, 12LSZD60020, 12LSZD60021, 12LSZD60024, 12LSZD60025, 12LSZD60026, 12LSZD60027, 12LSZD60028, 12LSZD60029, 12LSZD60030, 12LSZD60031, 12LSZD60032, 12LSZD60033, 12LSZD60034, 12LSZD60035, 12LSZD60036, 12LSZD60037, 12LSZD60040, 12LSZD60042, 12LSZD60043,12LSZD60044, 12LSZD60046, 12LSZD60047, 12LSZD60048, 12LSZD60049, 12LSZD60050, 12LSZD60051, 12LSZD60052, 12LSZD60053, 12LSZD60054,12LSZD60055, 12LSZD60056, 12LSZD60058, 12LSZD60059, 12LSZD60063, 12LSZD60064, 12LSZD60067, 12LSZD60068, 12LSZD60069, 12LSZD60070, 12LSZD60071, 12LSZD60072, 12LSZD60073, 12LSZD60074, 12LSZD60075, 12LSZD60076, 12LSZD60077, 12LSZD60078, 12LSZD60079, 12LSZD60080, 12LSZD60081, 12LSZD60083, 12LSZD60084, 12LSZD60085, 12LSZD60086, 12LSZD60088, 12LSZD60089, 12LSZD60091, 12LSZD60093, 12LSZD60094, 12LSZD60095, 12LSZD60096, 12LSZD60097, 12LSZD60098, 12LSZD60099, 12LSZD60100, 12LSZD60101, 12LSZD60102, 12LSZD60103, 12LSZD60104, 12LSZD60105, 12LSZD60107, 12LSZD60109, 12LSZD60110, 12LSZD60112, 12LSZD60113, 12LSZD60114, 12LSZD60115, 12LSZD60116, 12LSZD60117, 12LSZD60121, 12LSZD60122, 12LSZD60123, 12LSZD60124, 12LSZD60126, 12LSZD60127, 12LSZD60128, 12LSZD60129, 12LSZD60130, 12LSZD60131, 12LSZD60132, 12LSZD60134, 12LSZD60135, 12LSZD60136, 12LSZD60137, 12LSZD60139, 12LSZD60140, 12LSZD60141, 12LSZD60142, 12LSZD60144, 12LSZD60145, 12LSZD60146, 12LSZD60147, 12LSZD60149, 12LSZD60150, 12LSZD60151, 12LSZD60152, 12LSZD60155, 12LSZD60156, 12LSZD60158, 12LSZD60159, 12LSZD60160, 12LSZD60161, 12LSZD60162, 12LSZD60163, 12LSZD60164, 12LSZD60167, 12LSZD60168, 12LSZD60169, 12LSZD60170, 12LSZD60171, 12LSZD60172, 12LSZD60173, 12LSZD60174, 12LSZD60175, 12LSZD60176, 12LSZD60177, 12LSZD60178, 12LSZD60181, 12LSZD60182, 12LSZD60185, 12LSZD60187, 12LSZD60190, 12LSZD60192, 12LSZD60193, 12LSZD60194, 12LSZD60195, 12LSZD60197, 12LSZD60198, 12LSZD60199, 12LSZD60200, 12LSZD60201, 12LSZD60202, 12LSZD60203, 12LSZD60205, 12LSZD60206, 12LSZD60207, 12LSZD60208, 12LSZD60209, 12LSZD60210, 12LSZD60211, 12LSZD60212, 12LSZD60213, 12LSZD60214, 12LSZD60215, 12LSZD60216, 13CSZD60001, 13CSZD60002, 13CSZD60003, 13CSZD60004, 13CSZD60005, 13CSZD60006, 13CSZD60008, 13CSZD60009, 13CSZD60011, 13CSZD60013, 13CSZD60015, 13CSZD60016, 13CSZD60018, 13CSZD60019, 13CSZD60022, 13CSZD60023, 13CSZD60024, 13CSZD60025, 13CSZD60026, 13CSZD60028, 13CSZD60029, 13CSZD60031, 13CSZD60032, 13CSZD60034, 13CSZD60035, 13CSZD60036, 13CSZD60037, 13CSZD60039, 13CSZD60040, 13CSZD60041, 13CSZD60042, 13CSZD60044, 13CSZD60045, 13CSZD60046, 13CSZD60047, 13CSZD60048, 13CSZD60050, 13CSZD60051, 13CSZD60052, 13CSZD60054, 13CSZD60055, 13CSZD60056, 13CSZD60057, 13CSZD60058, 13CSZD60059, 13CSZD60066, 13CSZD60071, 13CSZD60072, 13CSZD60074, 13CSZD60075, 13CSZD60076, 13CSZD60077, 13CSZD60078, 13CSZD60079, 13CSZD60080, 13CSZD60082, 13CSZD60083, 13CSZD60084, 13CSZD60085, 13CSZD60087, 13CSZD60088, 13CSZD60091, 13CSZD60093, 13CSZD60095, 13CSZD60097, 13CSZD60098, 13CSZD60099, 13CSZD60100, 13CSZD60101, 13CSZD60102, 13CSZD60103, 13CSZD60104, 13CSZD60105, 13CSZD60107, 13CSZD60108, 13CSZD60110, 13CSZD60112, 13CSZD60113, 13CSZD60114, 13CSZD60115, 13CSZD60116, 13CSZD60117, 13CSZD60118, 13CSZD60119, 13CSZD60128, 13CSZD60130, 13CSZD60131, 13CSZD60133, 13CSZD60134, 13CSZD60135, 13CSZD60136, 13CSZD60138, 13CSZD60140, 13CSZD60141, 13CSZD60144, 13CSZD60146, 13CSZD60147, 13CSZD60148, 13CSZD60149, 13CSZD60150, 13CSZD60151, 13CSZD60153, 13CSZD60154, 13CSZD60155, 13CSZD60156, 13CSZD60157, 13CSZD60159, 13CSZD60163, 13CSZD60164, 13CSZD60166, 13CSZD60167, 13CSZD60168, 13CSZD60170, 13CSZD60171, 13CSZD60173, 13CSZD60175, 13CSZD60178, 13CSZD60180, 13CSZD60182, 13CSZD60183, 13CSZD60188, 13CSZD60189, 13CSZD60191, 13CSZD60193, 13CSZD60194, 13CSZD60198. 13CSZD60199, 13CSZD60200, 13CSZD60201, 13CSZD60203, 13CSZD60204, 13CSZD60205, 13CSZD60207, 13CSZD60208, 13CSZD60211, 13CSZD60213, 13CSZD60214, 13CSZD60215, 13CSZD60216, 13CSZD60219, 13CSZD60224, 13CSZD60225, 13CSZD60227, 13CSZD60229, 13DSZD60001, 13DSZD60002, 13DSZD60003, 13DSZD60004, 13DSZD60005, 13DSZD60007, 13DSZD60008, 13DSZD60010, 13DSZD60012, 13DSZD60013, 13DSZD60015, 13DSZD60016, 13DSZD60017, 13DSZD60019, 13DSZD60020, 13DSZD60021, 13DSZD60023, 13DSZD60024, 13DSZD60026, 13DSZD60027, 13DSZD60029, 13DSZD60030, 13DSZD60032, 13DSZD60033, 13DSZD60034, 13DSZD60035, 13DSZD60036, 13DSZD60037, 13DSZD60039, 13DSZD60040, 13DSZD60041, 13DSZD60042, 13DSZD60043, 13DSZD60044, 13DSZD60045, 13DSZD60046, 13DSZD60047, 13DSZD60055, 13DSZD60056, 13DSZD60057, 13DSZD60058, 13DSZD60059, 13DSZD60060, 13DSZD60061, 13DSZD60062, 13DSZD60065, 13DSZD60066, 13DSZD60067, 13DSZD60068, 13DSZD60069, 13DSZD60074, 13DSZD60075, 13DSZD60076, 13DSZD60077, 13DSZD60078, 13DSZD60079, 13DSZD60080, 13DSZD60081, 13DSZD60082, 13DSZD60084, 13DSZD60085, 13DSZD60086, 13DSZD60087, 13DSZD60088, 13DSZD60089, 13DSZD60091, 13DSZD60092, 13DSZD60095, 13DSZD60096, 13DSZD60097, 13DSZD60098, 13DSZD60099, 13DSZD60100, 13DSZD60101, 13DSZD60102, 13DSZD60103, 13DSZD60104, 13DSZD60105, 13DSZD60107, 13DSZD60108, 13DSZD60109, 13DSZD60110, 13ESZD60002, 13ESZD60003, 13ESZD60004, 13ESZD60005, 13ESZD60007, 13ESZD60008, 13ESZD60009, 13ESZD60010, 13ESZD60011l, 13ESZD60012, 13ESZD60014, 13ESZD60015, 13ESZD60016, 13ESZD60017, 13ESZD60018, 13ESZD60019, 13ESZD60020, 13ESZD60021, 13ESZD60022, 13ESZD60023, 13ESZD60024, 13ESZD60025, 13ESZD60027, 13ESZD60030, 13ESZD60031, 13ESZD60032, 13ESZD60033, 13ESZD60034, 13ESZD60035.13ESZD60036, 13ESZD60037, 13ESZD60038, 13ESZD60039, 13ESZD60040, 13ESZD60041, 13FSZD60001, 13FSZD60002, 13FSZD60003, 13FSZD60004, 13FSZD60005, 13FSZD60006, 13FSZD60009, 13FSZD60011, 13FSZD60012, 13FSZD60013, 13FSZD60014, 13FSZD60015, 13FSZD60016, 13FSZD60017, 13FSZD60018, 13FSZD60019, 13FSZD60020, 13FSZD60021, 13FSZD60022, 13FSZD60023, 13FSZD60024, 13FSZD60025, 13FSZD60027, 13FSZD60030, 13FSZD60031, 13FSZD60032, 13FSZD60033, 13FSZD60034, 13FSZD60035, 13FSZD60036, 13FSZD60037, 13FSZD60040, 13FSZD60041, 13FSZD60042, 13FSZD60043, 13FSZD60044, 13FSZD60045, 13FSZD60048, 13FSZD60049, 13FSZD60050, 13FSZD60051, 13FSZD60052, 13FSZD60053,13FSZD60054, 13FSZD60055, 13FSZD60056, 13FSZD60057, 13FSZD60058, 13FSZD60060, 13FSZD60061, 13FSZD60062, 13FSZD60063, 13FSZD60064, 13FSZD60067, 13FSZD60068, 13FSZD60069, 13FSZD60070, 13FSZD60071, 13FSZD60072, 13FSZD60075, 13FSZD60076, 13FSZD60078, 13FSZD60079, 13FSZD60080, 13FSZD60081, 13FSZD60082, 13FSZD60084, 13FSZD60085, 13FSZD60086, 13FSZD60088, 13FSZD60089, 13FSZD60094, 13FSZD60096, 13FSZD60097, 13FSZD60098, 13FSZD60100, 13FSZD60101, 13FSZD60102,13FSZD60103, 13FSZD60104, 13FSZD60106, 13FSZD60107, 13FSZD60111, 13FSZD60112, 13FSZD60114, 13FSZD60115, 13FSZD60118, 13FSZD60119, 13FSZD60120, 13FSZD60121, 13GSZD60001, 13GSZD60003, 13GSZD60004, 13GSZD60006, 13GSZD60007, 13GSZD60010, 13GSZD60011, 13GSZD60013, 13GSZD60014, 13GSZD60015, 13GSZD60016, 13GSZD60017, 13GSZD60018, 13GSZD60019, 13GSZD60022, 13GSZD60023, 13GSZD60024, 13GSZD60025, 13GSZD60026, 13GSZD60027, 13GSZD60030, 13GSZD60031, 13GSZD60032, 13GSZD60033, 13GSZD60036, 13GSZD60037, 13GSZD60038, 13GSZD60040, 13GSZD60042, 13GSZD60043, 13GSZD60045, 13GSZD60046, 13GSZD60048, 13HSZD60004, 13HSZD60005, 13HSZD60006, 13HSZD60007, 13HSZD60009, 13HSZD60010, 13HSZD60011, 13HSZD60013, 13HSZD60014, 13HSZD60015, 13HSZD60017, 13JSZD60002, 13JSZD60004, 13JSZD60010, 13JSZD60011, 13JSZD60013, 13JSZD60014, 13JSZD60015, 13JSZD60017, 13JSZD60018, 13JSZD60019, 13JSZD60020, 13JSZD60021, 13JSZD60023, 13JSZD60026, 13JSZD60034, 13JSZD60035, 13JSZD60037, 13JSZD60038, 13JSZD60039, 13JSZD60040, 13JSZD60041, 13JSZD60043, 13JSZD60045, 13JSZD60046, 13JSZD60047, 13JSZD60048, 13JSZD60049, 13JSZD60050, 13JSZD60051, 13JSZD60052, 13JSZD60053, 13JSZD60054, 13JSZD60055, 13JSZD60058, 13JSZD60060, 13JSZD60061, 13JSZD60063, 13JSZD60064, 13JSZD60065, 13JSZD60067, 13JSZD60069, 13JSZD60071, 13JSZD60074, 13JSZD60076, 13JSZD60077, 13JSZD60078, 13JSZD60079, 13JSZD60080, 14ESZD60005, 14ESZD60007, 14ESZD60008, 14ESZD60015, 14ESZD60016, 14ESZD60020, 14ESZD60021, 14ESZD60023, 14ESZD60024, 14ESZD60025, 14ESZD60038, 14ESZD60039, 14ESZD60044,14ESZD60057, 14ESZD60058, 14ESZD60061, 14ESZD60062, 14ESZD60063, 14ESZD60067, 14ESZD60069, 14ESZD60070, 14ESZD60071, 14ESZD60075, 14ESZD60076, 14ESZD60078, 14ESZD60080, 14ESZD60082, 14ESZD60087, 14ESZD60089, 14ESZD60090, 14ESZD60092, 14ESZD60093, 14ESZD60094, 14ESZD60096, 14ESZD60101, 14ESZD60103, 14ESZD60104, 14ESZD60105, 14ESZD60106, 14ESZD60108, 14ESZD60109, 14ESZD60111, 14ESZD60112, 14ESZD60113 & 14ESZD60114. Model #AIRPTMBDY20, Serial #s: 12KSZD60009, 12KSZD60025, 12KSZD60084, 12KSZD60097, 12KSZD60104, 12KSZD60132, 12KSZD60135, 12KSZD60150, 12LSZD60016, 12LSZD60045, 12LSZD60061, 12LSZD60065, 12LSZD60082, 12LSZD60087, 12LSZD60111, 12LSZD60119, 12LSZD60143, 12LSZD60148, 12LSZD60153, 13CSZD60021, 13CSZD60049, 13CSZD60060, 13CSZD60106, 13CSZD60111, 13CSZD60123, 13CSZD60129, 13CSZD60142, 13CSZD60158, 13CSZD60192, 13CSZD60202, 13CSZD60210, 13DSZD60004, 13DSZD60006, 13DSZD60011, 13DSZD60022, 13DSZD60038, 13DSZD60050, 13DSZD60051, 13DSZD60052, 13DSZD60054, 13ESZD60001, 13ESZD60013, 13ESZD60026, 13FSZD60007, 13FSZD60026, 13FSZD60029, 13FSZD60077, 13FSZD60091, 13FSZD60092, 13FSZD60095, 13FSZD60099, 13GSZD60029, 13GSZD60044, 13HSZD60012, 13HSZD60016, 13JSZD60024, 13JSZD60033, 13JSZD60044, 13JSZD60056, 13JSZD60066, 14ESZD60017, 14ESZD60018, 14ESZD60027, 14ESZD60037, 14ESZD60040, 14ESZD60077, 14ESZD60081, 14ESZD60083 & 14ESZD60084. Model #AIRPTBASE, Serial #s: 12KSZD60068, 12KSZD60119, 12LSZD60106, 12LSZD60166, 12LSZD60180, 13CSZD60092, 13DSZD60063, 13DSZD60064, 13DSZD60090, 13FSZD60008, 13FSZD60028, 13FSZD60046, 13FSZD60047, 13HSZD60001, 13JSZD60001, 13JSZD60068, 14ESZD60014, 14ESZD60022, 14ESZD60065, 14ESZD60068, 14ESZD60072, 14ESZD60074, 14ESZD60086, 14ESZD60088, 14ESZD60091, 14ESZD60097, 14ESZD60098, 14ESZD60102 & 14ESZD60107.
• Recalling Firm/ Manufacturer: Invacare Corporation; 1 Invacare Way; Elyria OH 44035-4190
• For Additional Information Contact: Invacare Recall Support Line; 877-413-6008
• Manufacturer Reason for Recall: The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.
• FDA Determined Cause: Device Design
• Action: Invacare sent an " Urgent Medical Device Recall " letter on April 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You should immediately contact your provider at the number below so a replacement batteries can be installed. If you have any questions concerning these instructions, please call Invacares recall support line at (877) 413-6008, Monday  Friday, 8 a.m.  5 p.m. EST, for assistance. Visit www.invacare.com/recall for more information about this recall.
• Quantity in Commerce: 1,057 finished devices
• Distribution: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO
• 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.

• 510(K) Database: 510(K)s with Product Code = ITI and Original Applicant = INVACARE CORP.