Events

Recall of Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Science & Engineering, Inc..

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
    71696
  • Event Risk Class
    Class 2
  • Event Number
    Z-2206-2015
  • Event Initiated Date
    2015-05-22
  • Event Date Posted
    2015-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138765
  • 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
    Cabinet x-ray, security (includes baggage x-ray) - Product Code RCG
  • Reason
    During factory testing, we discovered that gemini systems could, in rare circumstances, experience a fault that leads to a state in which x-rays are being produced but the x-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.
  • Action
    American Science Engineering, Inc (AS&E;) is developing a fix for this problem that includes updating a software configuration on the X-ray source. You will be notified by field service as soon as this update is available. Please inform all operators of the system about this communication, so they are aware of the need to shut down and re-start the system should this fault occur. We appreciate your understanding. if you have any questions, please feel free to contact AS&E; via e-mail at service@as-e.com. If you are under a service contract, you can also contact your customer service representative. For further questions please call (978) 262-8700.

Device

Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system
  • Model / Serial
    Gemini systems
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : NY, FL, TN, PA, NJ, DE, ME, TX, CT, MS, NC, MD, MO, VA, DC, NV and GA., and to the countries of : Saudi Arabia, Indonesia, Canada, Netherlands, Hong Kong, Lebanon and Kazakhstan.
  • Product Description
    American Science & Engineering Inc,Gemini Cabinet X-ray system.
  • Manufacturer
    American Science & Engineering, Inc.

Manufacturer

American Science & Engineering, Inc.
  • Manufacturer Address
    American Science & Engineering, Inc., 829 Middlesex Tpke, Billerica MA 01821-3907
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA