Device Recall Lateral biopsy plate

  • Model / Serial
    All lot codes.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.
  • Product Description
    The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is labeled in part: Lateral Biopsy Plate, part 2414346, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The lateral biopsy plate is packaged and sold as a part of catalogue E8800BG, M3087JG, G3087JH, M3335LA.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    USA Instruments Incorporated, 1515 Danner Dr, Aurora OH 44202-9273
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    LOT 6318910'', expiration date 09/2007.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual.
  • Manufacturer