Events

Device Recall LEO Scooter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invacare Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60670
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0774-2012
  • 사례 시작날짜
    2011-12-07
  • 사례 출판 날짜
    2012-01-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106176
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Vehicle, motorized 3-wheeled - Product Code INI
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 제조사 주소
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • 제조사 모회사 (2017)
    Invacare Corporation
  • Source
    USFDA