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.
Recall
- Recall Number
- Z-0516-2007
- Event Number
- 37263
- Firm
- USA Instruments Incorporated
- FEI Number
- 3005214683
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 31, 2007
- Posted
- February 15, 2007
- Terminated
- April 13, 2012
- Address
- 1515 Danner Dr, Aurora, OH, 44202-9273
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.
The packaging used for the Breast Biopsy plate may exhibit small holes or tears
The recalling firm notified consignees via certified letter, dated 1/31/07.
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.
Approximately 2200 units for all products being recalled