510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-2358-2015Class II

Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria...

Invacare GmbH / initiated 2015-02-02 / Terminated / root cause: design
FDA source (opens on fda.gov)

Invacare Corporation began a recall of Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2358-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
Product code
ITI Wheelchair, Powered
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.
Root cause tag
design
FDA root 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
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2358-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2358-2015Class IITerminatedVoluntary: Firm initiated