ClearanceBrief
Recall Z-0505-2007 ยท LNH System, Nuclear Magnetic Resonance Imaging

USA Instruments Incorporated

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

DateFeb 15, 2007 (initiated Nov 21, 2006)
StatusTerminated
ReasonThe packaging used for the Breast Biopsy Plate may exhibit small holes or tears.
Root causeOther
ActionCustomers were notifed by certified letter, dated 11/28/06.
Quantity250 units
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K041695LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
Usa Instruments, Inc., Jul 23, 2004
K0525853T HD BREAST ARRAY
Usa Instruments, Inc., Oct 4, 2005