Device Recall Penner Patient Transfer/Lift System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Penner Mfg 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
    56977
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1912-2011
  • 사례 시작날짜
    2009-01-19
  • 사례 출판 날짜
    2011-04-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-04-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Lift, patient, ac-powered - Product Code FNG
  • 원인
    Incomplete weld on the pillar mounting bracket.
  • 조치
    The firm, Penner, sent an undated letter flagged "Important Safety Inspection: Action Required" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax to 402 694-5844 or mail to Penner Manufacturing Inc, 102 Grant Street, Aurora, NE 68818, Attn: Quality Assurance Manager. Penner stated in the letter, if welds are not complete (no weld), discontinue use and contact the Quality Assurance Manager at Penner Manufacturing immediately at 402-694-5003. If you have any questions, contact the Quality Assurance Manager at 402-694-5003.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model 382000-1 - Serial numbers 07030456102, 05030435303, 07030456101, 07030456103, 05030435301, 09030479202, 09030479201, 09030479205, 11030501601, 07030456104, 11030501602, 11030501604, 12030507602, 12030507601, 12030507603, 11030501603, 09030479203, 12030507604, 11030501605, 12030509803, 07030435302, 12030509802, 12030507605, 12030509805, 01040535102, 01040535103, 06040623302, 06040623303, 01040535101, 06040623304, 07040635502, 07040635501, 07040635503, 06040623301, 07040635504, 07040635505, 07040635506, 07040635601, 07040635602, 07040635603, 07040635604, 08040665602, 07040635605, 08040665601, 07040635606, 08040665603, 08040665604, 12030509804, 08040665605, 09040678702, 09040678701, 09040678703, 09040678704, 11040712001, 11040712002, 11040712003, 11040712004, 11040712005, 01050741002, 01050741003, 01050741004, 01050741005, 02050756702, 02050756704, 02050756701, 03050798302, 03050798305, 03050790404, 02050756703, 03050798301, 03050790402, 03050798304, 03050790401, 03050798303, 03050790403, 06050840201, 06050840202,  06050840203, 06050840204, 06050840205, 06050840206, 06050840207, 03050790405, 06050840209, 08050884101, 06050840210, 08050884401, 08050884404, 10050924102, 10050924101, 10050924103, 10050924106, 11050939502, 10050924105, 11050939503, 10050924104, 11050939601, 11050939501, 11050939504, 11050939603, 11050939604, 02060988902, 11050939602, 02060988903, 06061061801, 02060988904, 02060988901, 06061061804, 09061105901, 08050884403, 08061096702, 08061096703, 10061134503, 06071297106, 07071328104, 06050840208, and 01050741001.   Model 382000-1L - Serial numbers 03050798604, 03050798602, 2050756901, 03050798601, 06050845901, 03050798603, 06050867102, 08050884701, 06050845902, 06050867104, 06050867103, 08050884702, 08050884703, 08050884704, 01060954301, 01060971601, 01060954302, 01060971604, 01060971602, 01060971603, 02060989001, 02060989002, 06050867101, 02060989004, 02060989003, 02060989005, 02060989006, 06061061901, and 06061061902.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Canada and Mexico.
  • 제품 설명
    Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models 382000-1 (right entry) and 382000-1L (left entry). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. || For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Penner Mfg Inc, 102 Grant St Ste A, Aurora NE 68818-3200
  • Source
    USFDA