Events

Device Recall Actical 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mini-Mitter Company, Inc. 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
    38368
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0325-2008
  • 사례 시작날짜
    2007-06-27
  • 사례 출판 날짜
    2008-01-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53494
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    Patient Physiological Monitor - Product Code M HX
  • 원인
    Communication failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. if left unaddressed, the issues can lead to permanent communication failure.
  • 조치
    A Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession. Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required. Min-Mitter will provide a new one year warranty.

Device

Device Recall Actical
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: B100001, B100002, B100003, B100005, B100006, B100007, B100008, B100009, B100023, B100024, B100025, B100026, B100027, B100028, B100029, B100030, B100031, B100032, B100033, B100034, B100035, B100036, B100037, B100038, B100039, B100041, B100042, B100043, B100044, B100045, B100046, B100047, B100048, B100049, B100050, B100051, B100052, B100053, B100054, B100055, B100056, B100057, B100058, B100059, B100060, B100061, B100062, B100063, B100064, B100065, B100066, B100067, B100068, B100069, B100070, B100071, B100072, B100073, B100074, B100075, B100076, B100077, B100078, B100079, B100080, B100081, B100082, B100083, B100084, B100085, B100086, B100087, B100088, B100089, B100090, B100091, B100092, B100093, B100094, B100095, B100096, B100097, B100098, B100099, B100100, B100101, B100102, B100103, B100104, B100105, B100106, B100107, B100108, B100109, B100110, B100111, B100112, B100113, B100114, B100115, B100116, B100117, B100118, B100119, B100120, B100121, B100122, B100123, B100124, B100125, B100126, B100127, B100128, B100129, B100130, B100131, B100132, B100133, B100134, B100135, B100136, B100137, B100138, B100139, B100140, B100141, B100142, B100143, B100144, B100145, B100146, B100147, B100148, B100149, B100150, B100151, B100152, B100153, B100154, B100155, B100156, B100157, B100158, B100159, B100160, B100161, B100162, B100163, B100164, B100165, B100166, B100167, B100168, B100169, B100170, B100171, B100172, B100173, B100174, B100175, B100176, B100177, B100178, B100179, B100180, B100181, B100182, B100183, B100184, B100185, B100186, B100187, B100188, B100189, B100190, B100191, B100192, B100193, B100194, B100195, B100196, B100197, B100198, B100199, B100200, B100201, B100202, B100203, B100204, B100205, B100206, B100207, B100208, B100209, B100210, B100211, B100212, B100213, B100214, B100215, B100216, B100217, B100218, B100219, B100220, B100221, B100222, B100223, B100224, B100225, B100226, B100227, B100228, B100229, B100230, B100231, B100232, B100233, B100234, B100235, B100236, B100237, B100238, B100239, B100240, B100241, B100242, B100243, B100244, B100245, B100246, B100247, B100248, B100249, B100250, B100251, B100252, B100253, B100254, B100255, B100256, B100257, B100258, B100259, B100260, B100261, B100262, B100263, B100264, B100265, B100266, B100267, B100268, B100269, B100270, B100271, B100272, B100273, B100274, B100275, B100276, B100277, B100278, B100279, B100280, B100281, B100282, B100283, B100284, B100285, B100286, B100287, B100288, B100289, B100290, B100291, B100292, B100293, B100294, B100295, B100296, B100297, B100298, B100299, B100300, B100301, B100302, B100303, B100304, B100305, B100306, B100307, B100308, B100309, B100310, B100311, B100312, B100313, B100314, B100315, B100316, B100317, B100318, B100319, B100320, B100321, B100322, B100323, B100324, B100325, B100326, B100327, B100328, B100329, B100330, B100331, B100332, B100333, B100334, B100335, B100336, B100337, B100338, B100339, B100340, B100341, B100342, B100343, B100344, B100345, B100346, B100347, B100348, B100349, B100350, B100351, B100352, B100353, B100354, B100355, B100356, B100357, B100358, B100359, B100360, B100361, B100362, B100363, B100364, B100365, B100366, B100367, B100368, B100369, B100370, B100371, B100372, B100373, B100374, B100375, B100376, B100377, B100378, B100379, B100380, B100381, B100382, B100383, B100384, B100385, B100386, B100387, B100388, B100389, B100390, B100391, B100392, B100393, B100394, B100395, B100396, B100397, B100398, B100399, B100400, B100401, B100402, B100403, B100406, B100407, B100408, B100409, B100410, B100411, B100412, B100413, B100414, B100415, B100416, B100417, B100418, B100419, and B100420
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide
  • 제품 설명
    Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon
  • Manufacturer
    Mini-Mitter Company, Inc.

Manufacturer

Mini-Mitter Company, Inc.
  • 제조사 주소
    Mini-Mitter Company, Inc., 20300 Empire Ave Ste B3, Bend OR 97701
  • 제조사 모회사 (2017)
    Mini Mitter Co Inc
  • Source
    USFDA