Events

Device Recall HARMONIC Blue Hand Piece & HARMONIC Hand Piece 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon Endo-Surgery 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
    61540
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1673-2012
  • 사례 시작날짜
    2012-03-16
  • 사례 출판 날짜
    2012-05-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108394
  • 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
    Instrument, ultrasonic surgical - Product Code LFL
  • 원인
    Ethicon endo-surgery initiated a voluntary recall due to some lot numbers of the harmonic¿ hand piece (hp054) and the harmonic¿ blue hand piece (hpblue), which impacts their compatibility with the harmonic¿ generator 300 (gen04). the problem occurs after successful set up and initial use of harmonic¿ hand pieces (hp054 and hpblue) with the generator 300 (gen04). the procedure is interrupted when.
  • 조치
    Ethicon Endo-Surgery Inc sent an URGENT: Product Correction Notification letter dated March 2012 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Labels were enclosed that are used to identify the recalled product. Customers were instructed to fill out the Business Reply Form and fax it to Stericycle at 1-888-912-7091 within three business days for a credit. For questions regarding this recall call 513-337-3419.

Device

Device Recall HARMONIC Blue Hand Piece & HARMONIC Hand Piece
  • 모델명 / 제조번호(시리얼번호)
    HARMONIC¿ HP054 Hand Pieces Lot Numbers produced to-date: H92Y3M, J9039C, J90817, J90E7C, J9000C, J90432, J9084W, J90E7Z, J90029, J90470, J9088L, J90F3G,J9006C, J9054E, J9093L, J90F7Z, J9011D, J9056K, J9095C, J90G32, J90151, J9057V,J90974, J90G9Y,J9018H, J9058L, J90A45, J90H37,J9020F, J90624, J90A72, J90H4U, 9023D, J90681, J90C7X, J90H7D,J9027C, J9069F, J90C84, J90H9Y,J90314, J90726, J90D4N, J90J2N,J9034N, J90762, J90E0R, J90J8E,J9038W, J9076A, and J90E29.   HARMONIC¿ HPBLUE Hand Pieces Lot Numbers produced to-date: J9001P, J9053N, J9091G, J90D84,J9005J, J9057E, J90A2C, J90E55,J9010E, J9065U, J90A64, J90F76,J9042G, J90696, J90C36, J90G4C,J9050E, J9086W, J90C7U, and J90H46.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including: AK,AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NCND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, and WY. and the countries of: Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Ecuador, Egypt, Greece, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Korea (South),Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Antilles, Pakistan, Panama, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Taiwan, Thailand, Turkey, United Arab Emirates Uruguay, Venezuela & Yemen.
  • 제품 설명
    HPBLUE: HARMONIC¿ Blue Hand Piece; HP054: HARMONIC¿ Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. || Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • 제조사 주소
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA