Z-0518-2007

The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part...

Name: Z-0518-2007 The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part...
Creator: USA Instruments Incorporated
Published: 2007-01-31
License: https://open.fda.gov/license/

GE Healthcare Coils / initiated 2007-01-31 / Terminated / root cause: packaging

FDA source

USA Instruments Incorporated began a recall of 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... on 2007-01-31. The reason FDA records is "The packaging used for the Breast Biopsy plate may exhibit small holes or tears". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0518-2007
Status: Terminated
Initiated: 2007-01-31
Posted: 2007-02-15
Terminated: 2012-04-13
Recalling firm: GE Healthcare Coils
Product: 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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The packaging used for the Breast Biopsy plate may exhibit small holes or tears
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm notified consignees via certified letter, dated 1/31/07.
Quantity in commerce: 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 Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.
Product codes and lots: All lot codes

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)