Manufacturers

USA Instruments Incorporated

7 devices in the database

3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System
  • Model / Serial
    The following Serial Numbers of this device were subject to recall: 101, 102, 201, 202, 203, 204, 205, 206, 207, 309, 310.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.
  • Product Description
    3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.
1.5T HD Head Neck Spine Array, Model 2416329.
  • Model / Serial
    The following Serial Numbers of this device were subject to recall: 101, 201, 202, 203, 204, 205, 206, 207, 208, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, and 329.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.
  • Product Description
    1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.
Device Recall Large grid biopsy plate
  • Model / Serial
    All lot codes
  • Product Classification
    Radiology Devices
  • 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 Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. || The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277.
Device Recall Disposable biopsy plate
  • Model / Serial
    All lot codes
  • Product Classification
    Radiology Devices
  • 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 Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, 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 and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.
Device Recall Lateral biopsy plate
  • Model / Serial
    All lot codes.
  • Product Classification
    Radiology Devices
  • 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.
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