Events

Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Osypka Medical 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
    56121
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2444-2010
  • 사례 시작날짜
    2010-06-30
  • 사례 출판 날짜
    2010-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93070
  • 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
    pulse-generator, pacemaker, external - Product Code DTE
  • 원인
    The recall was initiated after osypka medical received two (2) complaints from their japanese distributor regarding an incompatibility of the pace 203h with some new types of 9 v batteries. the investigation revealed that pace 203h of a certain manufacturing period malfunction (i.E., not stimulate) when a type of 9 v batteries with higher than usual open circuit voltage (ocv) is used. failure t.
  • 조치
    OSYPKA Medical sent "Urgent Medical Device Recall" letters dated June 30, 2010 and July 7, 2010 to the direct customers. The recall notice informed the customers of the Reason for Recall, the Potential Hazard, the Temporary Fix of the Problem, the Permanent Fix of the Problem and Recommended Actions to be taken by the customer. The customers were instructed to contact Osypka Medical via telephone (858) 454-0021 or e-mail to m.osypka@osypkamed.com to verify that the Model 3085 and/or PACE 203H is subject to this product removal, obtain a return-to-manufacturer-authorization (RMA) number ,and then return the affected devices to Osypka Medical. If you have any questions call (858) 454-0021 or e-mail to mail@osypkamed.com

Device

Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator
  • 모델명 / 제조번호(시리얼번호)
    S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: USA including states of CA & FL
  • 제품 설명
    St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator || The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
  • Manufacturer
    Osypka Medical Inc

Manufacturer

Osypka Medical Inc
  • 제조사 주소
    Osypka Medical Inc, 7855 Ivanhoe Ave Ste 226, La Jolla CA 92037-4561
  • 제조사 모회사 (2017)
    Osypka Medical Inc
  • Source
    USFDA