Events

Recall of Device Recall LATERAL BIOPSY PLATE, For use with the Liberty 9000 8 channel breast coil

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by USA Instruments Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36866
  • Event Risk Class
    Class 2
  • Event Number
    Z-0505-2007
  • Event Initiated Date
    2006-11-21
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49474
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    biopsy plate - Product Code LNH
  • Reason
    The packaging used for the breast biopsy plate may exhibit small holes or tears.
  • Action
    Customers were notifed by certified letter, dated 11/28/06.

Device

Device Recall LATERAL BIOPSY PLATE, For use with the Liberty 9000 8 channel breast coil
  • Model / Serial
    LOT 6318910'', expiration date 09/2007.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    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.
  • Manufacturer
    USA Instruments Incorporated

Manufacturer

USA Instruments Incorporated
  • Manufacturer Address
    USA Instruments Incorporated, 1515 Danner Dr, Aurora OH 44202-9273
  • Source
    USFDA