Z-0505-2007

LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent...

Name: Z-0505-2007 LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent...
Creator: USA Instruments Incorporated
Published: 2006-11-21
License: https://open.fda.gov/license/

GE Healthcare Coils / initiated 2006-11-21 / Terminated / root cause: packaging

FDA source

USA Instruments Incorporated began a recall of 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)... on 2006-11-21. 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-0505-2007
Status: Terminated
Initiated: 2006-11-21
Posted: 2007-02-15
Terminated: 2012-04-13
Recalling firm: GE Healthcare Coils
Product: 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.
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: Customers were notifed by certified letter, dated 11/28/06.
Quantity in commerce: 250 units
Distribution: Nationwide.
Product codes and lots: ''LOT 6318910'', expiration date 09/2007.

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)