Events

Device Recall SSeries Headpiece Long Range 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Bionics LLC 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
    50204
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0958-2009
  • 사례 시작날짜
    2008-07-24
  • 사례 출판 날짜
    2009-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76843
  • 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
    cochlear implant - Product Code MCM
  • 원인
    Mistuned headpiece - advanced bionics recently became aware of a tuning issue with some platinum series and s-series headpieces shipped from may 2007 through april 2008. tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. potential clinical symptoms include: -no lock -intermittent lock -implant locks, but can.
  • 조치
    Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the number of headpiece-related complaints, firm advises of the potential clinical symptoms: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps. Per the letter, as long as the system maintains lock, there is no degradation in sound quality or stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal. Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.

Device

Device Recall SSeries Headpiece Long Range
  • 모델명 / 제조번호(시리얼번호)
    a) Model AB-5301-00 (biege); Serial Numbers: 14532, 14544, 14546, 14590, 14591, 14592, 14593, 14594, 14595, 14596, 14597, 14598, 14599, 14600, 14601, 14602, 14603, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14650, 14654, 14655, 14657, 14663, 14666, 14669, 14670, 14671, 14678, 14679, 14680, 14681, 14682, 14683, 14684, 14685, 14687, 14688, 14690, 14691, 14694, 14695, 14696, 14697, 14698, 14699, 14700, 14702, 14703, 14704, 14705, 14706, 14707, 14708, 14709, 15269, 15272, 15303, 15304, 15305, 15306, 15307, 15308, 15309, 15310, 15311, 15312, 15313, 15314, 15315, 15316, 15317, 15318, 15319, 15320, 15321, 15322, 15323, 15324, 15325, 15326, 15327, 15328, 15329, 15330, 15331, 15332, 15483, 15484, 15485, 15486, 15487, 15488, 15489, 15490, 15491, 15492, 15493, 15496, 15497, 15499, 15500, 15501, 15502 and 15504. b) Model AB-5301-10 (brown), Serial Numbers: 11112, 11113, 11114, 11115, 11121, 11123, 11124, 11125, 11126, 11129, 11160, 11161, 11163, 11164, 11165, 11166, 11167, 11169, 11170, 11171, 11172, 11173, 11174, 11175, 11176, 11177, 11178, 11179, 11180, 11181, 11182, 11183, 11184, 11185, 11186, 11188, 11189, 11190, 11191, 11196, 11201, 11208, 11215, 11216, 11217, 11218, 11250, 11251, 11254, 11255, 11256, 11257, 11259, 11260, 11261, 11262, 11263, 11265, 11267, 11269, 11270, 11271, 11272, 11273, 11274, 11275, 11277, 11278, 11280, 11281, 11282, 11283, 11284, 11285, 11286, 11287, 11288, 11289, 11290, 11291, 11292, 11293, 11294, 11295, 11296, 11297, 11298, 11299, 11300, 11301, 11302, 11303, 11304, 11305, 11306, 11307, 11308, 11309, 11324, 11325, 11326, 11327, 11328, 11329, 11330, 11331, 11332, 11333, 11334, 11406, 11413, 11414, 11416, 11418, 11430, 11432, 11435, 11437, 11438, 11439, 11443, 11445, 11446, 11449, 11452, 11453, 11454, 11499, 11501, 11508, 11510 and 11517.
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
  • Manufacturer
    Advanced Bionics LLC

Manufacturer

Advanced Bionics LLC
  • 제조사 주소
    Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • 제조사 모회사 (2017)
    Sonova Holding Ag
  • Source
    USFDA