Device Recall Medial 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 medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, 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 medial biopsy plate, part #2414342 is packaged and sold as a part of catalogue numbers E8800BF, M3087JG, G3087JH, and M3335LA.
  • Manufacturer
  • 1 Event

Manufacturer

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