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Terminated

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 procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277.

FDA Recall Z-0519-2007 · Posted 2007-02-15

Recalling FirmUSA Instruments Incorporated
Recall StatusTerminated
Product CodeLNH
Date Initiated2007-01-31
Date Terminated2012-04-13
Product QuantityApproximately 2200 units for all products being recalled

Reason for Recall

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

Firm Action

The recalling firm notified consignees via certified letter, dated 1/31/07.

Root Cause

Other

Distribution Pattern

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.

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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