Device Recall GE Healthcare Innova IGS 530

  • Model / Serial
    Serial Number System ID Not Available 702731CATH3 0000013C2R0003 6012883100CV4 15C2R0084 702880CATH2 15C2R0086 GON4300165 15C2R0085 918787530 15C2R0087 814877EP 0000015C2R0091 GON1441141 0000014C2R0188 XV650620BU8 0000015C2R0083 GON1487269 0000015C2R0088 GON4271086 0000015C2R0064 080041RX18 15C2R0055 414649IGS2 15C2R0072 GON4211904 0000015C2R0074 0004077351 0000015C2R0066 082416190029 0000015C2R0070 082416100092 0000015C2R0071 082416190026
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
  • Product Description
    GE Healthcare Innova IGS 530. || Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA