Device Recall Terumo APS 1

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0011 through 0039, 0041 through 0308, 0310 through 0313, 0315, 0316, 0319 through 0321 and 0324 may be affected by this issue. Serial numbers 0238 and 0282 have been corrected to date.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.
  • 제품 설명
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 20 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • 제품 설명
    Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0093 and 0104 through 0114.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
  • 제품 설명
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0040 through 0044.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
  • 제품 설명
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0011 through 0039 and 0041 through 0170.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
  • 제품 설명
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0006 through 0066.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
  • 제품 설명
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
  • Manufacturer
하나 더 15 건 더