Events

Spacelabs Healthcare CardioCall ECG Event Recorder 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare 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
    72211
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0172-2016
  • 사례 시작날짜
    2015-09-03
  • 사례 출판 날짜
    2015-10-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-09-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140208
  • 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
    Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
  • 원인
    When the battery is inserted into the cardiocall ecg event recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. the device has a self-test failure and will not operate normally.
  • 조치
    Spacelabs Healthcare sent an Urgent-Medical Device Correction letter, dated September 17, 2015 to US consignees (Hospital Administrator/Biomedical Manager/Office Manager). The firm plans to email a customer letter (translated as necessary) to international subsidiaries and distributors of record on 9/25/15. Customers were informed Spacelabs Healthcare will send a replacement CardioCall ECG Event Recorder(s) at no cost and a prepaid method to ease the return of the affected CardioCall device(s) back to Spacelabs. For additional information or technical assistance contact: Global Technical Support Spacelabs Healthcare, Ltd. 1 Harforde Court, John Tate Road Hertford SG13 7NW United Kingdom + 44 (0) 1992 507700 For USA Technical Support call 1-800-522-7025 and select 2 for Technical Support

Device

Spacelabs Healthcare CardioCall ECG Event Recorder
  • 모델명 / 제조번호(시리얼번호)
    PCBAs PN #: 670-1670-00.  SERIAL NUMBERS in the US:  CARD-200990, CARD-201287, CARD-623478, CARD-623775, CARD-624198, CARD-624224, CARD-624314, CARD-624387, CARD-624404, CARD-624413, CARD-624891, CARD-625061, CARD-625089, CARD-625124, CARD-625232, CARD-625269, CARD-625296, CARD-625304, CARD-625322, and CARD-625421.  SERIAL NUMBERS OUTSIDE THE US:  CARD-000019, CARD-000028, CARD-000037, CARD-000046, CARD-000064, CARD-000073, CARD-000073, CARD-000082, CARD-000091, CARD-000109, CARD-000118, CARD-000127, CARD-000136, CARD-000145, CARD-000163, CARD-000172, CARD-000181, CARD-000190, CARD-000208, CARD-000217, CARD-000226, CARD-000235, CARD-000244, CARD-000271, CARD-000280, CARD-000299, CARD-000307, CARD-000325, CARD-000334, CARD-000343, CARD-000352, CARD-000361, CARD-000370, CARD-000398, CARD-000406, CARD-000415, CARD-000424, CARD-000433, CARD-000442, CARD-000451, CARD-000479, CARD-000479, CARD-000488, CARD-000497, CARD-000505, CARD-000514, CARD-000523, CARD-000532, CARD-000550, CARD-000578, CARD-000596, CARD-000604, CARD-000613, CARD-000622, CARD-000631, CARD-000640, CARD-000659, CARD-000668, CARD-000677, CARD-000686, CARD-000703, CARD-000721, CARD-000730, CARD-000749, CARD-000758, CARD-000767, CARD-000776, CARD-000785, CARD-000785, CARD-000794, CARD-000802, CARD-000811, CARD-000820, CARD-000820, CARD-000839, CARD-000848, CARD-000857, CARD-000866, CARD-000875, CARD-000893, CARD-000910, CARD-000910, CARD-000929, CARD-000938, CARD-000947, CARD-000956, CARD-000974, CARD-000983, CARD-000992, CARD-001009, CARD-001018, CARD-001027, CARD-001027, CARD-001036, CARD-001045, CARD-001054, CARD-001063, CARD-001072, CARD-001072, CARD-001081, CARD-001090, CARD-001108, CARD-001117, CARD-001135, CARD-001144, CARD-001153, CARD-001171, CARD-001180, CARD-001199, CARD-001199, CARD-001207, CARD-001216, CARD-001225, CARD-001234, CARD-001243, CARD-001252, CARD-001261, CARD-001270, CARD-001289, CARD-001298, CARD-001306, CARD-001315, CARD-001333, CARD-001379, CARD-001388, CARD-001397, CARD-001405, CARD-001414, CARD-001423, CARD-001441, CARD-001603, CARD-002602, CARD-003304, CARD-003601, CARD-003908, CARD-005203, CARD-006103, CARD-200035, CARD-200116, CARD-200125, CARD-200486, CARD-200963, CARD-201016, CARD-201052, CARD-201124, CARD-201133, CARD-300016, CARD-300025, CARD-300034, CARD-300052, CARD-300070, CARD-300089, CARD-300098, CARD-300160, CARD-300188, CARD-300197, CARD-300205, CARD-300214, CARD-300223, CARD-300232, CARD-300269, CARD-300278, CARD-300313, CARD-300322, CARD-300331, CARD-300368, CARD-300395, CARD-300412, CARD-300421, CARD-300430, CARD-300458, CARD-300467, CARD-300476, CARD-300494, CARD-300511, CARD-300539, CARD-300548, CARD-300566, CARD-300576, CARD-300647, CARD-300656, CARD-300674, CARD-300692, CARD-300728, CARD-300755, CARD-300773, CARD-300782, CARD-300809, CARD-300818, CARD-300836, CARD-300881, CARD-300890, CARD-300917, CARD-300926, CARD-300944, CARD-301006, CARD-301042, CARD-301079, CARD-301114, CARD-301150, CARD-301178, CARD-301439, CARD-301484, CARD-400213, CARD-621894, CARD-623973, CARD-624846, CARD-625043, CARD-625160, CARD-625188, CARD-625250, CARD-625476, CARD-625511, CARD-625665, CARD-625818, CARD-627023, CARD-627546, CARD-627555, CARD-627564, CARD-627636, CARD-627645, CARD-627654, CARD-627663, CARD-627672, CARD-627708, CARD-627726, CARD-627744, CARD-627753, CARD-627771, CARD-627780, CARD-627834, CARD-627861, CARD-627898, CARD-627960, CARD-627997, CARD-628013, CARD-628031, CARD-628059, CARD-628077, CARD-628095, CARD-628112, CARD-628176, CARD-628220, CARD-628239, CARD-630065, CARD-630137, CARD-630146, CARD-630281, CARD-630443, CARD-630461, CARD-630498, CARD-630885, CARD-631235, CARD-631271, and CARD-631307.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, ITALY, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, QATAR, SINGAPORE, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • 제품 설명
    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 || Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • 제조사 주소
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA