Terminated

The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, 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 and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.

FDA Recall Z-0518-2007 · 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. · 2005-10-04 K041695LIBERTY 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.