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Terminated

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.

FDA Recall Z-0505-2007 · Posted 2007-02-15

Recalling FirmUSA Instruments Incorporated
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-11-21
Date Terminated2012-04-13
Product Quantity250 units

Reason for Recall

The packaging used for the Breast Biopsy Plate may exhibit small holes or tears.

Firm Action

Customers were notifed by certified letter, dated 11/28/06.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0525853T HD BREAST ARRAYUsa Instruments, Inc. · 2005-10-04K041695LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATEUsa Instruments, Inc. · 2004-07-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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