Events

Device Recall ATAR eusable Extension Cables 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Oscor, 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
    76884
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2340-2017
  • 사례 시작날짜
    2017-03-31
  • 사례 출판 날짜
    2017-04-10
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154469
  • 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
    Cable, electrode - Product Code IKD
  • 원인
    The reusable oscor atar extension cables could separate form the connector during use when the instructions for reuse are not being followed.
  • 조치
    Oscor sent an Important Information letter dated March 27, 2017, to all affected customers. The letter explained that they awee aware the Reusable Oscor ATAR extension cables could separate from the connector during use when instructions for use were not followed. They pointed out to consignees that if reused, they can only be reused a maximum of 2 times and must be resterilized by Oscor EtO. Customers were notified again, when the recall expanded on 06/01/2017, and were sent notifications on 06/05/2017. Instructions to customers included to examine inventory, quarantine any affected devices, notify customers if further distributed, and contact Oscor to arrange for replacement. Customers were notified a third time when the recall expanded on 06/13/2017, and notifications were sent between 06/23/2017 and 07/01/2017. Instructions included to check inventory, quarantine any affected devices, return the Acknowledgement Form, and return affected cables to Oscor. Customers with questions should call 727-937-2511.

Device

Device Recall ATAR eusable Extension Cables
  • 모델명 / 제조번호(시리얼번호)
    Model Code (Lot #): 53912 - MDTS ATAR REUSABLE (D2-02245 D2-02269 D2-02304 D2-02310 OR-04362 D2-02459 D2-02487 D2 02622 D2-02669 D2-02683 D2-02734 D2-02684 D2-02773 D2-02795 D2-02853 D2-02854 D2-02852 D2-02947 D2-02946 D2-02945 OR-04680 D2-03029 D2-02953 D2-03050 D2-03107 OR-04694 D2-03059 D2-03058 D2 03050 OR-04693 D2-03161 D2-03201 D2-03186 D2-03236 D2-03607 D2-03798 D2-03877 D2-03763 D2-03797 D2-03774 D2-03545 D2-03546 D2-03547 D2-03554 D2-03568 D2-03570 D2-03799 D2-03606 D2-03800 D2-03627 D2-03626 D2-03729 D2-03730 D2-03731 D2-03732 D2-03755 D2-03756 D2-03757 D2-03758 D2-03761 D2-03762 D2-03571 D2-03867 D2-03777 D2-03884 D2-03882 D2-03783 D2-03883 D2-03899 D2-03880 D2-03898 D2-03782 D2-03878 D2-03879 D2-03778 D2-03779 D2-03781 D2-03908 D2-03780 D2-03902 D2-03906 D2-03907 D2-03905 D2-03942 D2-03912 D2-03999 D2-04001 D2-03913 D2-02622), 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE (D2-01835 D2-02144 D2-02304 D2-02621 D2-02773 D2-02795 D2-03058 D2-02765 D2-03290 D2-03204 D2-03185 D2-03184 D2-03236 D2-03443 D2-02551 D2-02749 D2-03161 D2-02683 D2-02948 D2-03544 D2-02269 OR-04362 D2-02459 D2-02245 D2-03881 D2-01821 D2-03203 D2-03237 D2-03446 D2-03911 DP-02832 D2 02538 DP-03150 OR-04694 D2-03150 D2-03148 D2-03152 D2-03059 D2-03151 D2-03543 D2-03221 D2 03290 D2-03287 D2-03202 D2 03543 D2-03445 D2-03757 D2-03777 D2-03899 D2-03878 D2-03912 D2-03914), ATAR-A DARK BLUE REUSABLE (D2-02776 D2-03741 D2-01574 D8-00030 D2-01779 D8-00011 D2-01779 00 D2-02389 D2 02389 D2-03176 D2-03092 D2-03334 D2-03040 D2-01764 DP-02398 D2-02349 D2-02369 D2-03574 D2 03334 D2-03691 D2-03964 D8-00011-00 D2-02076 D2-02194 D2-03695 D2 01779 D2-01493 D2 02076 D2-02535 D2-03639 D2 01938 D2-01938 00 D2-02503 D2-01938 D2-02359 C1-06065 D2-01654 D2 01714 OR-03910 D2-02109 D2-02526 D2-03600 D2-03629 D2-03652 D2-02824 D2-02398 D2-02468 D2-01679 D2-02937 D2 02468 D2 02503 OR-04391 D2- 02503 D2-02476 OR-04393 D2-01714 D2-01714-0 D2 01779-00 D2 01714-00 D2 02194 OR-04118 D2-03864 D2-01722 D2-02136), ATAR-MDT REUSABLE (D2-02766 D2-02514. D2-02933 D2-02949 D2-02950 D2 02514 D2-02537 D2-03576 D2-02987 D2-02366 D2-02431 D202537 D2-02906 OR-03644 D2-01837 D2-02514 DP-02933 DP-02949 D2 02986 OR-03498 OR-03499 D2-01807 D2-01832 OR-03921 D2-02055 D2-01837. D2 01837 OR-04361 D2-02111 D2-02598 D2 02537 D2 02766 D2-02986 D2-04033 D2-03982), ATAR-MDT2 REUSABLE (D2-02583 D2-02336 D2-01797 D2-03768 D2-03523 D2-02541 D2-03512 D2-03651 D2-03748 D2-03769 D2-02582 D2-03955), ATAR-MDT2S-A DK BLUE 30CM REUSABLE (C1-08831 D2-04131), ATAR-MDT2S-V WHITE 30CM REUSABLE (C1-08830 D2-04002), ATAR-MDTL REUSABLE (D8-00005 D2-01352-00), ATAR-MDTR REUSABLE (D2-02210 D2 02211 D2-02833 D2-02211), ATAR-R REUSABLE (D2-03922 D2-01665), ATAR-R T4P REUSABLE (D2-03560), ATAR-R1 REUSABLE (D2-03022 D2-03603 DP-02660 EN-11196 OR-04350 D2-01763 OR-03790 D2 03022 D2-04208 D2-02770 D2-02778 D2-02660), ATAR-RL REUSABLE (D8-00026 D2-01846 D8-00025 D2-02057 D2-01677 D2-02142 D2-03689 D2-03744 D2 03744 D2-03578 D2-04012 OR-03967 D2-02396), ATAR-T REUSABLE (D2-03078 D2 02140 D2-02465 D2-02580 D2 02515 D2-02928 D2-03292 D2-02515 D2-04152 D2-03653 D2-03954 D2-02929 D2 03726 D2 02140. D2-02056 D2-01836 D2-03726 D2-01796 D2-0256 D2-02140 D2-02140. D202140 D2.02140 D2 02580 D2-02772 D2-03575 D2-02963 D2-03726. D2-04013 D2 04152 D2-04247 OR-03975 D2-01016-01 D2-01016-02), ATAR-V WHITE REUSABLE (D2-02588 D2-03857 D8-00012 D2 01780 D8 00012 D2-02350 D2 02302 D2-03174 D2-03305 D2-03034 D2-03055 D2-03093 D2-03696 D2-01680 OR-03909 D2 02137 D2-02536 D2-02025 D2-01780 00 DP-02904 D2-02464 D2-03036 D2-01780 D2 01575 D2-02506 D2-02137 D2-02302 D2-03789 D2-02110 D2-01575 D2-03605 D2-03640 D202764 D2-03956 D2-01715 D2 02350 D2-02764 D2-01488 D2-02467 D8-00012-00 D8-00031 D2-01655 D2 01715 D2-02137. D2-02488 D2-03452 D2-03597 D2-03562 D2-03630 DOR01003 OR-04438 D2 02536 D2 02764 D2-02904 D2-03035 D2-03692 D2-03693), ATAR-V2 REUSABLE (D2-02787 D2-02647), XI.A DARK BLUE REUSABLE (D2-01938 DP-01001 D2-02136 D2-02358 D2-02398 D2-02441 D2-02476 EG-01326 EG 01326 EG-01369 D2-03062), XI.MDT REUSABLE (D2-02055 D2-02364 D2-02480 D2-02450 OR-04361 D2-02514 D2-02451 D2-02860 D2-02867 D2 02364 D2-02772 D2 02867 D2-02906 D2-02868 D2-02964 D2-03329 D2 03329 D2-03575 D2-03501 D2-02986 D2 02964 D2-03860 D2-03982 D2-04090 D2 04090 D2-04120), XI.R REUSABLE (D2-01665 D2-02141 D2-02423 D2-02449 D2-02486), XI.V WHITE (DP-01024 D2-02248 DP 01024 D2-02302 D2-02359 D2 02248 D2-02350 D2-02395 D2-02452 D2-02577 EG-01328 EG-01328 EG-01328 D2-03063)
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -US to AL, AK, CA, CO, FL, GA, ID, IL, IN, IA , KS, KY, ME, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, DC. Foreign distribution to following countries: Macedonia, Pakistan, Austria, Canada, Guatemala, United Kingdom, Republic of Panama, Chile, Aruba, Saudi Arabia, Kuwait, Costa Rica, Albania, Estonia, New Zealand, Germany, Puerto Rico, Turkey, Virgin Islands, Iraq, Hong Kong, and Morocco,
  • 제품 설명
    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. || Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE || Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
  • Manufacturer
    Oscor, Inc.

Manufacturer

Oscor, Inc.
  • 제조사 주소
    Oscor, Inc., 3816 Desoto Blvd, Palm Harbor FL 34683-1618
  • 제조사 모회사 (2017)
    Oscor Inc.
  • Source
    USFDA