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

  • 모델명 / 제조번호(시리얼번호)
    S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
  • 의료기기 분류등급
  • 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
  • 1 Event

제조사

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