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.
Description du dispositif
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.
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.