Events

Recall of Device Recall Hamamatsu Microfocus Xray Source

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
    60991
  • Event Risk Class
    Class 2
  • Event Number
    Z-1224-2012
  • Event Initiated Date
    2011-03-30
  • Event Date Posted
    2012-03-29
  • 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=106996
  • 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 that the micro focus x-ray source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator.
  • Action
    Hamamtsu Corporation sent a Warning letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CDRH approves your CAP under the following conditions: 1. Hamamatsu is able to work with your manufacturer customers to assure the revised manual and new label are provided to your customers' end users. 2. Hamamatsu informs CDRH if you receive information which indicates this control defect has occurred. Relevant information includes direct communication from customers or through observation of excessive wear on returned x-ray tubes. For questions regarding this recall call 908-231-0960, ext 2300.

Device

Device Recall Hamamatsu Microfocus Xray Source
  • Model / Serial
    Series L8601, L9121, L7901, and L8031
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) and the country of Canada.
  • Product Description
    Hamamatsu Corporation, Bridgewater NJ 08807 || Microfocus X-ray Source || L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), || L7901 series, and L8031 series (100kV type MICROFOCUS || x-ray source
  • 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