Events

Recall of Device Recall Micro Focus XRay generator

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

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
    59760
  • Event Risk Class
    Class 2
  • Event Number
    Z-3076-2011
  • Event Initiated Date
    2011-07-07
  • Event Date Posted
    2011-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103604
  • 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
    industrial x-ray - Product Code RBS
  • Reason
    It was discovered about a potential issue of x-ray leakage with our model # li1 0951-35 micro focus x-ray generator.
  • Action
    Hamamatsu Corporation sent a letter dated July 19, 2011, to the manufacturer and their subcontractor informing them of the affected product and what they propose to do. They will repair the units both in the field and those returned to our plant by installing additional lead shielding in the units. The lead shielding will be fixed to the unit by soldering the addition to the existing lead shield (see attachment 2). We expect to complete the repair of all units in the field by October 1, 2011. All new units to be shipped from our plant will be repaired before shipment. For further questions, please call (908) 231-0960 X 2300

Device

Device Recall Micro Focus XRay generator
  • Model / Serial
    Model # L10951-35 Serial number SII00002 through SII00009.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.
  • Product Description
    Hamamatsu model L10951-35 Micro Focus x-ray generator. || The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies.
  • Manufacturer
    Hamamatsu Corporation

Manufacturer

Hamamatsu Corporation
  • Manufacturer Address
    Hamamatsu Corporation, 360 Foothill Rd, Bridgewater NJ 08807
  • Manufacturer Parent Company (2017)
    Hamamatsu Photonics K.K.
  • Source
    USFDA