Device Recall Advance

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.
  • Product Description
    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, 9900 Innovation Drive, Mail Stop: RP2138, Wauwatosa WI 53226
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

16 devices with a similar name

Learn more about the data here

  • Model / Serial
    all codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
  • Product Description
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
  • Manufacturer
  • Model / Serial
    all codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
  • Product Description
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 17282012, 17283012, 17297012, 17298012  UDI: (01)4546540055415
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
  • Product Description
    Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 || for orthopedic use.
  • Manufacturer
  • Model / Serial
    Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Advance¿ Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.
  • Manufacturer
  • Model / Serial
    Lot numbers 544531 to 544548 and 544502 to 544504.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped nationwide to medical facilities.
  • Product Description
    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
  • Manufacturer
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