Device Recall BleaseSirius Anaesthesia Machine

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: DOMESTIC - siri-001852, siri-002292, SIRI-002081, SIRI-002082, SIRI-002085, SIRI-002089, SIRI-002091, SIRI-002097, SIRI-002099, SIRI-002101, SIRI-002102, SIRI-001851, SIRI-001818, SIRI-001819, SIRI-001821, SIRI-001822, SIRI-001823, SIRI-001824, SIRI-001825, SIRI-001826, SIRI-001827, SIRI-001828, SIRI-001829, SIRI-002106, and SIRI-002108.   INTERNATIONAL - siri-001861, siri-001853, siri-001855, siri-001857, SIRI-001905, SIRI-002363, SIRI-001948, SIRI-001949, SIRI-001950, SIRI-001951, SIRI-001952, SIRI-001846, SIRI-001847, SIRI-001848, SIRI-001849, SIRI-001921, SIRI-001961, SIRI-001963, SIRI-001964, siri-002139, SIRI-002162, SIRI-002298, SIRI-002349, SIRI-002354, SIRI-001611, SIRI-001612, SIRI-001614, SIRI-001615, SIRI-001616, SIRI-001617, SIRI-002157, siri-002135, SIRI-2302, siri-001903, siri-001904, siri-001911, SIRI-002041, SIRI-001858, SIRI -002150, SIRI-002156, siri-002166, siri-002168, siri-002169, siri-002171, siri-002201, SIRI-001854, SIRI-001785, SIRI-001786, SIRI-001954, SIRI-001850, SIRI-001862, SIRI-002159, SIRI-002304, SIRI-002315, and SIRI-002224.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of IA, GA, LA, NC, TN, and TX and countries of AUSTRALIA, CHILE, CHINA, INDIA, ITALY, PHILIPPINES, MEXICO, POLAND, SINGAPORE, THAILAND, TURKEY, UNITED KINGDOM, and VENEZUELA.
  • 제품 설명
    BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England || Intended for use in the hospital environment and operating room.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
  • Source
    USFDA