Recall Z-0519-2007 ยท LNH System, Nuclear Magnetic Resonance Imaging
USA Instruments Incorporated
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 procedu
| Date | Feb 15, 2007 (initiated Jan 31, 2007) |
| Status | Terminated |
| Reason | The packaging used for the Breast Biopsy plate may exhibit small holes or tears. |
| Root cause | Other |
| Action | The recalling firm notified consignees via certified letter, dated 1/31/07. |
| Quantity | Approximately 2200 units for all products being recalled |
| 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 |
| FDA record | Open on fda.gov |