Events

Rappel de Device Recall LEO Scooter

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
    60670
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0774-2012
  • Date de mise en oeuvre de l'événement
    2011-12-07
  • Date de publication de l'événement
    2012-01-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106176
  • 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
    Vehicle, motorized 3-wheeled - Product Code INI
  • Cause
    Invacare corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury.
  • Action
    On 12/7/2011 the firm sent Urgent: Recall Information Letters to their customers. The letter informed customers of the affected product and the related problem. The letter also states that Invacare has developed replacement seat kits intended to replace the original seats. The replacement kit will be provided free of charge and can be ordered by completing and returning the attached response card. After receiving replacement kits, customers are asked to contact their customers that have potentially affected devices and replace the seats immediately. Questions should be directed to Customer Service at 1-800-333-6900.

Device

Device Recall LEO Scooter
  • Modèle / numéro de série
    Model # LEO-4B; Serial # 10MCT000110, 10MCT000111, 10MCT000112, 10MCT000113, 10MCT000114, 10MCT000115, 10MCT000116, 10MCT000117, 10MCT000118, 10MCT000119, 10MCT000120, 10MCT000121, 10MCT000122, 10MCT000123, 10MCT000124, 10MCT000125, 10MCT000126, 10MCT000127, 10MCT000128, 10MCT000129, 10MCT000130, 10MCT000131, 10MCT000132, 10MCT000133, 10MCT000134, 10MCT000135, 10MCT000136, 10MCT000137, 10MCT000138, 10MCT000139, 10MCT000140, 10MCT000141, 10MCT000142, 10MCT000143, 10MCT000144, 10MCT000145, 10MCT000146, 10MCT000147, 10MCT000148, 10MCT000149, 10MCT000150, 10MCT000151, 10MCT000152, 10MCT000153, 10MCT000154, 10MCT000155 & 10MCT000156. Model # LEO-4S; Serial # 10MCT000001, 10MCT000002, 10MCT000003, 10MCT000004, 10MCT000005, 10MCT000006, 10MCT000007, 10MCT000008, 10MCT000009, 10MCT000010, 10MCT000011, 10MCT000012, 10MCT000013, 10MCT000014, 10MCT000015, 10MCT000016, 10MCT000017, 10MCT000018, 10MCT000019, 10MCT000020, 10MCT000021, 10MCT000022, 10MCT000023, 10MCT000024, 10MCT000025, 10MCT000026, 10MCT000027, 10MCT000028, 10MCT000029, 10MCT000030, 10MCT000031, 10MCT000032, 10MCT000033, 10MCT000034, 10MCT000035, 10MCT000036, 10MCT000037, 10MCT000038, 10MCT000039, 10MCT000040, 10MCT000041, 10MCT000042, 10MCT000043, 10MCT000044, 10MCT000045, 10MCT000046, 10MCT000047, 10MCT000048, 10MCT000049, 10MCT000050, 10MCT000051, 10MCT000052, 10MCT000053, 10MCT000054, 10MCT000055, 10MCT000056, 10MCT000057, 10MCT000058, 10MCT000059, 10MCT000060, 10MCT000061, 10MCT000062, 10MCT000063, 10MCT000064, 10MCT000065, 10MCT000066, 10MCT000067, 10MCT000068, 10MCT000069, 10MCT000070, 10MCT000071, 10MCT000072, 10MCT000073, 10MCT000074, 10MCT000075, 10MCT000076, 10MCT000077, 10MCT000078, 10MCT000079, 10MCT000080, 10MCT000081, 10MCT000082, 10MCT000083, 10MCT000084, 10MCT000085, 10MCT000086, 10MCT000087, 10MCT000088, 10MCT000089, 10MCT000090, 10MCT000091, 10MCT000092, 10MCT000093, 10MCT000094, 10MCT000095, 10MCT000096, 10MCT000097, 10MCT000098, 10MCT000099, 10MCT000100, 10MCT000101, 10MCT000102, 10MCT000103, 10MCT000104, 10MCT000105, 10MCT000106, 10MCT000107, 10MCT000108, 10MCT000109, 10MDG0001, 10MDG0002, 10MDG0003, 10MDG0004, 10MDG0005, 10MDG0006, 10MDG0007, 10MDG0008, 10MDG0009, 10MDG0010, 10MDG0011, 10MDG0012, 10MDG0013, 10MDG0014, 10MDG0015, 10MDG0016, 10MDG0017, 10MDG0018, 10MDG0019, 10MDG0020, 10MDG0021, 10MDG0022, 10MDG0023, 10MDG0024, 10MDG0025, 10MDG0026, 10MDG0027, 10MDG0028, 10MDG0029, 10MDG0030, 10MDG0047, 10MDG0048, 10MDG0049, 10MDG0050, 10MDG0051, 10MDG0052, 10MDG0053, 10MDG0054, 10MDG0055, 10MDG0056, 10MDG0057, 10MDG0058, 10MDG0059, 10MDG0060, 10MDG0061, 10MDG0062, 10MDG0063, 10MDG0064, 10MDG0065, 10MDG0066, 10MDG0067, 10MDG0068, 10MDG0069, 10MDG0070, 10MDG0071, 10MDG0072, 10MDG0073, 10MDG0074, 10MDG0075, 10MDG0076, 10MDG0077, 10MDG0078, 10MDG0079, 10MDG0080, 10MDG0081, 10MDG0082, 10MDG0083, 10MDG0084, 10MDG0085, 10MDG0086, 10MDG0087, 10MDG0088, 10MDG0089, 10MDG0090, 10MDG0091, 10MDG0092, 10MDG0093, 10MDG0094, 10MDG0095, 10MDG0096, 10MDG0097, 10MDG0098, 10MDG0099, 10MDG0100, 10MDG0101, 10MDG0102, 10MDG0103, 10MDG0104, 10MDG0105, 10MDG0106, 10MDG0107, 10MDG0108, 10MDG0109, 10MDG0110, 10MDG0111, 10MDG0112, 10MDG0113, 10MDG0114, 10MDG0115, 10MDG0116, 10MDG0117, 10MDG0118, 10MDG0119, 10MDG0120, 10MDG0121, 10MDG0122, 10MDG0123, 10MDG0124, 10MDG0125, 10MDG0126, 10MDG0127, 10MDG0128, 10MDG0129, 10MDG0130, 10MDG0131, 10MDG0132, 10MDG0133, 10MDG0134, 10MDG0135, 10MDG0151, 10MDG0152, 10MDG0153, 10MDG0154, 10MDG0155, 10MDG0156, 10MDG0157, 10MDG0158, 10MDG0159, 10MDG0160, 10MDG0161, 10MDG0162, 10MDG0163, 10MDG0164, 10MDG0165, 10MDG0166, 10MDG0167, 10MDG0168, 10MDG0169, 10MDG0170, 10MDG0171, 11ADG0001, 11ADG0002, 11ADG0003, 11ADG0004, 11ADG0005, 11ADG0006, 11ADG0007, 11ADG0008, 11ADG0009, 11ADG0010, 11ADG0011, 11ADG0012, 11ADG0013, 11ADG0014, 11ADG0015, 11ADG0016, 11ADG0017, 11ADG0018, 11ADG0019, 11ADG0020, 11ADG0021, 11ADG0022, 11ADG0023, 11ADG0024, 11ADG0025, 11ADG0026, 11ADG0027, 11ADG0028, 11ADG0029, 11ADG0030, 11ADG0031, 11ADG0032, 11ADG0033, 11ADG0034, 11ADG0035, 11ADG0036, 11ADG0037, 11ADG0038, 11ADG0039, 11ADG0040, 11ADG0041, 11ADG0042, 11ADG0073, 11ADG0074, 11ADG0075, 11ADG0076, 11ADG0077, 11ADG0078, 11ADG0079, 11ADG0080, 11ADG0081, 11ADG0082, 11ADG0083, 11ADG0084, 11ADG0085, 11ADG0086, 11ADG0087, 11ADG0088, 11ADG0089, 11ADG0090, 11ADG0091, 11ADG0092, 11ADG0093, 11ADG0094, 11ADG0095, 11ADG0096, 11ADG0097, 11ADG0098, 11ADG0099, 11ADG0100, 11ADG0101, 11ADG0102, 11ADG0103, 11ADG0104, 11ADG0105, 11ADG0106, 11ADG0107, 11ADG0108, 11ADG0109, 11ADG0110, 11ADG0111, 11ADG0112, 11ADG0113, 11ADG0114, 11ADG0115, 11ADG0116, 11ADG0117, 11ADG0118, 11ADG0119, 11ADG0120, 11ADG0121, 11ADG0122, 11ADG0123, 11ADG0124, 11ADG0125, 11ADG0126, 11ADG0127, 11ADG0128, 11ADG0129, 11ADG0130, 11ADG0131, 11ADG0132, 11ADG0133, 11ADG0134, 11ADG0135, 11ADG0136, 11ADG0137, 11ADG0138, 11ADG0139, 11ADG0140, 11ADG0141 & 11ADG0142.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of AK, CA, FL, GA, HI, IA, ID, IL, KS, LA, MD, MI, MN, MO, MT, NC, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, & WI, and the countries of AUSTRIA, BELGIUM, CZECH REPUBLIC, ESTONIA, FRANCE, GERMANY, IRELAND, ITALY, JERSEY (CHANNEL ISLANDS), LITHUANIA, PORTUGAL, SWEDEN, SWITZERLAND, & UNITED KINGDOM.
  • Description du dispositif
    Leo 3-Wheel Scooter and Leo Scooter, Distributed By: || Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 || Intended to provide transportation for a disabled or elderly person.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA