Events

Device Recall Elctrocardiograph Electrodes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leonhard Lang Medizintechnik GmbH 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
    72575
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0292-2016
  • 사례 시작날짜
    2015-11-02
  • 사례 출판 날짜
    2015-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141578
  • 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
    Electrode, electrocardiograph - Product Code DRX
  • 원인
    There is a risk ecg electrodes of specific lots fail to transmit signals. there is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.
  • 조치
    Leonhard Lang emailed an "Important Safety Notice" letter dated November 2, 2015, to all affected customers on November 2, 2015.. The letter identified the product the problem and the action needed to be taken by the customer. The letter provided information on: 1. Description of the defect; 2. Actions and time frame of the recall; 3. Replacement of the electrodes & contact information. For questions call : +43 512 33425-39.

Device

Device Recall Elctrocardiograph Electrodes
  • 모델명 / 제조번호(시리얼번호)
    List of models and lot numbers - USA Artikel No. Brand / Model Lot Nos. Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31113-0159 58051 Skintact W-60 (30/1200) 40304-0324 58051 Skintact W-60 (30/1200) 40325-0153 58051 Skintact W-60 (30/1200) 40326-0154 58051 Skintact W-60 (30/1200) 40416-0326 S&W; 620 58205 S&W; 620 31121-0155 58205 S&W; 620 31122-0156 58205 S&W; 620 31125-0159 58205 S&W; 620 40730-0324 58205 S&W; 620 40901-0328 58205 S&W; 620 50723-0326 58205 S&W; 620 50827-0329 Stable Base SBW55 50007 Stable Base SBW55 31104-0159 50007 Stable Base SBW55 31107-0321 50007 Stable Base SBW55 31108-0322 50007 Stable Base SBW55 31108-0323 50007 Stable Base SBW55 31111-0324 50007 Stable Base SBW55 31118-0325 50007 Stable Base SBW55 31119-0326 50007 Stable Base SBW55 31120-0327 50007 Stable Base SBW55 31121-0328 50007 Stable Base SBW55 31121-0329 50007 Stable Base SBW55 31122-0321 50007 Stable Base SBW55 31125-0322 50007 Stable Base SBW55 31129-0323 50007 Stable Base SBW55 31202-0324 50007 Stable Base SBW55 31203-0325 50007 Stable Base SBW55 40107-0323 50007 Stable Base SBW55 40107-0324 50007 Stable Base SBW55 40108-0325 50007 Stable Base SBW55 40109-0326 50007 Stable Base SBW55 40225-0157 50007 Stable Base SBW55 40226-0158 50007 Stable Base SBW55 40227-0151 50007 Stable Base SBW55 40227-0159 50007 Stable Base SBW55 40228-0152 50007 Stable Base SBW55 40303-0153 50007 Stable Base SBW55 40304-0154 50007 Stable Base SBW55 40304-0155 50007 Stable Base SBW55 40305-0156 Page 1 of 4 50007 Stable Base SBW55 40306-0157 50007 Stable Base SBW55 40307-0158 50007 Stable Base SBW55 40310-0159 50007 Stable Base SBW55 40311-0151 50007 Stable Base SBW55 40422-0328 50007 Stable Base SBW55 40428-0329 50007 Stable Base SBW55 40430-0321 50007 Stable Base SBW55 40505-0322 50007 Stable Base SBW55 40508-0323 50007 Stable Base SBW55 40512-0324 50007 Stable Base SBW55 40616-0152 50007 Stable Base SBW55 40618-0153 50007 Stable Base SBW55 40623-0154 50007 Stable Base SBW55 40625-0155 50007 Stable Base SBW55 40626-0156 50007 Stable Base SBW55 40630-0157 50007 Stable Base SBW55 40701-0158 50007 Stable Base SBW55 40703-0159 50007 Stable Base SBW55 40705-0151 50007 Stable Base SBW55 40708-0152 50007 Stable Base SBW55 40711-0153 50007 Stable Base SBW55 40714-0154 50007 Stable Base SBW55 40715-0155 50007 Stable Base SBW55 40717-0156 50007 Stable Base SBW55 40721-0157 50007 Stable Base SBW55 40722-0158 50007 Stable Base SBW55 40724-0159 50007 Stable Base SBW55 40725-0151 50007 Stable Base SBW55 40728-0152 50007 Stable Base SBW55 40731-0154 50007 Stable Base SBW55 40804-0155 50007 Stable Base SBW55 40805-0156 50007 Stable Base SBW55 40806-0157 50007 Stable Base SBW55 40808-0158 50007 Stable Base SBW55 40811-0159 50007 Stable Base SBW55 40812-0151 50007 Stable Base SBW55 40818-0152 50007 Stable Base SBW55 40819-0153 50007 Stable Base SBW55 40822-0154 50007 Stable Base SBW55 40825-0155 50007 Stable Base SBW55 40826-0157 50007 Stable Base SBW55 40828-0158 50007 Stable Base SBW55 40901-0159 50007 Stable Base SBW55 40902-0151 50007 Stable Base SBW55 40903-0152 50007 Stable Base SBW55 40903-0153 50007 Stable Base SBW55 40904-0154 50007 Stable Base SBW55 40908-0155 50007 Stable Base SBW55 40909-0156 50007 Stable Base SBW55 40911-0157 50007 Stable Base SBW55 40913-0158 50007 Stable Base SBW55 40925-0157 50007 Stable Base SBW55 40927-0158 50007 Stable Base SBW55 40930-0159 50007 Stable Base SBW55 41010-0323 50007 Stable Base SBW55 41013-0156 50007 Stable Base SBW55 41013-0324 50007 Stable Base SBW55 41015-0157 50007 Stable Base SBW55 41015-0325 50007 Stable Base SBW55 41016-0158 50007 Stable Base SBW55 41016-0326 50007 Stable Base SBW55 41017-0159 50007 Stable Base SBW55 41020-0151 50007 Stable Base SBW55 41021-0152 50007 Stable Base SBW55 41106-0152 50007 Stable Base SBW55 41107-0153 50007 Stable Base SBW55 41111-0154 50007 Stable Base SBW55 41113-0155 50007 Stable Base SBW55 41114-0156 50007 Stable Base SBW55 41117-0157 50007 Stable Base SBW55 50609-0152 50007 Stable Base SBW55 50610-0153 50007 Stable Base SBW55 50611-0154 50007 Stable Base SBW55 50615-0155 50007 Stable Base SBW55 50617-0156 50007 Stable Base SBW55 50618-0157 50007 Stable Base SBW55 50709-0158 50007 Stable Base SBW55 50710-0159 50007 Stable Base SBW55 50714-0151 50007 Stable Base SBW55 50715-0152 50007 Stable Base SBW55 50717-0153 50007 Stable Base SBW55 50720-0154 50007 Stable Base SBW55 50818-0151 50007 Stable Base SBW55 50820-0152 50007 Stable Base SBW55 50824-0153 50007 Stable Base SBW55 50826-0154 50007 Stable Base SBW55 50827-0155 50007 Stable Base SBW55 50828-0156 50007 Stable Base SBW55 50901-0157 50007 Stable Base SBW55 50910-0153 50007 Stable Base SBW55 50914-0154 50007 Stable Base SBW55 50916-0155 50007 Stable Base SBW55 50918-0156 50007 Stable Base SBW55 50921-0157 50007 Stable Base SBW55 50923-0158 Stable Base SBW55-15 50675 Stable Base SBW55-15 40729-0153 50675 Stable Base SBW55-15 41008-0154 50675 Stable Base SBW55-15 41009-0155 50675 Stable Base SBW55-15 50213-0321 50675 Stable Base SBW55-15 50218-0322 50675 Stable Base SBW55-15 50327-0156 50675 Stable Base SBW55-15 50401-0157 50675 Stable Base SBW55-15 50403-0158 50675 Stable Base SBW55-15 50408-0159 50675 Stable Base SBW55-15 50409-0151 50675 Stable Base SBW55-15 50902-0158 50675 Stable Base SBW55-15 50903-0159 50675 Stable Base SBW55-15 50907-0151 50675 Stable Base SBW55-15 50908-0152 Stable Base SBT60 50547 Stable Base SBT60 40314-0155 50547 Stable Base SBT60 40317-0156   List of models and lot numbers - outside USA Artikel No. Brand / Model Lot Nos. Skintact W-60HP E3 50476 Skintact W-60HP E3 31106-0246 50476 Skintact W-60HP E3 40226-0248 50476 Skintact W-60HP E3 40307-0249 50476 Skintact W-60HP E3 40324-0247 50476 Skintact W-60HP E3 50204-0247 50476 Skintact W-60HP E3 50601-0246 Skintact T-60 58046 Skintact T-60 40312-0329 58046 Skintact T-60 40313-0321 58046 Skintact T-60 40314-0322 Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31106-0152 58051 Skintact W-60 (30/1200) 31106-0153 58051 Skintact W-60 (30/1200) 31113-0158 58051 Skintact W-60 (30/1200) 31125-0158 58051 Skintact W-60 (30/1200) 31127-0151 58051 Skintact W-60 (30/1200) 31210-0321 58051 Skintact W-60 (30/1200) 31211-0322 58051 Skintact W-60 (30/1200) 31216-0158 58051 Skintact W-60 (30/1200) 31216-0159 58051 Skintact W-60 (30/1200) 40305-0325 58051 Skintact W-60 (30/1200) 40402-0159 58051 Skintact W-60 (30/1200) 40403-0151 58051 Skintact W-60 (30/1200) 40414-0324 58051 Skintact W-60 (30/1200) 40414-0325 58051 Skintact W-60 (30/1200) 40417-0327 58051 Skintact W-60 (30/1200) 40430-0156 58051 Skintact W-60 (30/1200) 40602-0326 58051 Skintact W-60 (30/1200) 40722-0328 58051 Skintact W-60 (30/1200) 40918-0321 58051 Skintact W-60 (30/1200) 41001-0326 58051 Skintact W-60 (30/1200) 41106-0329 58051 Skintact W-60 (30/1200) 41107-0321 58051 Skintact W-60 (30/1200) 41118-0325 58051 Skintact W-60 (30/1200) 41121-0327 58051 Skintact W-60 (30/1200) 50206-0327 58051 Skintact W-60 (30/1200) 50210-0328 58051 Skintact W-60 (30/1200) 50325-0155 58051 Skintact W-60 (30/1200) 50409-0329 58051 Skintact W-60 (30/1200) 50430-0329 58051 Skintact W-60 (30/1200) 50527-0322 58051 Skintact W-60 (30/1200) 50625-0322 58051 Skintact W-60 (30/1200) 50626-0323 58051 Skintact W-60 (30/1200) 50701-0324 58051 Skintact W-60 (30/1200) 50702-0325 58051 Skintact W-60 (30/1200) 50708-0327 Skintact W-60 (30/1200/4800) 58995 Skintact W-60 (30/1200/4800) 31112-0157 58995 Skintact W-60 (30/1200/4800) 40221-0153 58995 Skintact W-60 (30/1200/4800) 40430-0155 58995 Skintact W-60 (30/1200/4800) 50123-0159 58995 Skintact W-60 (30/1200/4800) 50901-0322 Skintact W-60 (30/300/1800) 59356 Skintact W-60 (30/300/1800) 31107-0154 59356 Skintact W-60 (30/300/1800) 31108-0155 59356 Skintact W-60 (30/300/1800) 31202-0154 59356 Skintact W-60 (30/300/1800) 40108-0153 59356 Skintact W-60 (30/300/1800) 40109-0154 59356 Skintact W-60 (30/300/1800) 40129-0152 59356 Skintact W-60 (30/300/1800) 40218-0159 59356 Skintact W-60 (30/300/1800) 40303-0323 59356 Skintact W-60 (30/300/1800) 40321-0151 59356 Skintact W-60 (30/300/1800) 40324-0152 59356 Skintact W-60 (30/300/1800) 40331-0158 59356 Skintact W-60 (30/300/1800) 40410-0323 59356 Skintact W-60 (30/300/1800) 40514-0327 59356 Skintact W-60 (30/300/1800) 40604-0327 59356 Skintact W-60 (30/300/1800) 40708-0322 59356 Skintact W-60 (30/300/1800) 40709-0323 59356 Skintact W-60 (30/300/1800) 40806-0329 59356 Skintact W-60 (30/300/1800) 40915-0329 59356 Skintact W-60 (30/300/1800) 41021-0329 59356 Skintact W-60 (30/300/1800) 41030-0325 59356 Skintact W-60 (30/300/1800) 41215-0329 59356 Skintact W-60 (30/300/1800) 50108-0158 59356 Skintact W-60 (30/300/1800) 50109-0159 59356 Skintact W-60 (30/300/1800) 50112-0151 59356 Skintact W-60 (30/300/1800) 50204-0326 59356 Skintact W-60 (30/300/1800) 50305-0326 59356 Skintact W-60 (30/300/1800) 50306-0327 59356 Skintact W-60 (30/300/1800) 50413-0321 59356 Skintact W-60 (30/300/1800) 50519-0327 59356 Skintact W-60 (30/300/1800) 50623-0159 59356 Skintact W-60 (30/300/1800) 50625-0151 59356 Skintact W-60 (30/300/1800) 50706-0326 59356 Skintact W-60 (30/300/1800) 50903-0326 59356 Skintact W-60 (30/300/1800) 50904-0327 Patz K920 58198 Patz K920 40219-0151 58198 Patz K920 40220-0152 58198 Patz K920 40808-0321 58198 Patz K920 50120-0157 58198 Patz K920 50917-0326 Dahlhausen 1900000440 58688 Dahlhausen 1900000440 31209-0329 58688 Dahlhausen 1900000440 40116-0151 58688 Dahlhausen 1900000440 40217-0158 58688 Dahlhausen 1900000440 40317-0323 58688 Dahlhausen 1900000440 40407-0329 58688 Dahlhausen 1900000440 40516-0328 58688 Dahlhausen 1900000440 40627-0326 58688 Dahlhausen 1900000440 40827-0327 58688 Dahlhausen 1900000440 40930-0325 58688 Dahlhausen 1900000440 41103-0326 58688 Dahlhausen 1900000440 41216-0321 58688 Dahlhausen 1900000440 50122-0158 58688 Dahlhausen 1900000440 50508-0323 58688 Dahlhausen 1900000440 50713-0329 58688 Dahlhausen 1900000440 50831-0321 Cardionetics CN-15-W60 59629 Cardionetics CN-15-W60 40115-0159 59629 Cardionetics CN-15-W60 40327-0155 59629 Cardionetics CN-15-W60 40606-0328 59629 Cardionetics CN-15-W60 41023-0321 59629 Cardionetics CN-15-W60 50119-0156 59629 Cardionetics CN-15-W60 50407-0326 59629 Cardionetics CN-15-W60 50812-0322 Lessa 99.832.02 58789 Lessa 99.832.02 40314-0097 58789 Lessa 99.832.02 40725-0093 EF Medica FS 50 LG 58872 EF Medica FS 50 LG 40307-0091 Ultragel FS50LG 50359 Ultragel FS50LG 40304-0098
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the state of : FL., and to the countries of : Australia, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Malta, Norway, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Thailand, Turkey and United Arab Emirates.
  • 제품 설명
    ECG Electrodes: || 50007  Stablebase SBW55 || 50675  Stablebase SBW55-15 || 58051  Skintact W-60 || 50547  Stablebase SBT60 || Only OUS: || 50476 Skintact W-60HP E3 I || 58046 Skintact T-60 I Patz K920 || 58688 Dahlhausen 1900000440 || 59629 Cardionetics CN-15-W60 || 58789 Lessa 99.832.02 || 58872 EF Medica FS 50 LG || 50359Ultragel FS50LG
  • Manufacturer
    Leonhard Lang Medizintechnik GmbH

Manufacturer

Leonhard Lang Medizintechnik GmbH
  • 제조사 주소
    Leonhard Lang Medizintechnik GmbH, Archenweg 56, Innsbruck Austria
  • Source
    USFDA