Events

Recall of Device Recall NOMAD Pro Packaged XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aribex 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
    74975
  • Event Risk Class
    Class 2
  • Event Number
    Z-2716-2016
  • Event Initiated Date
    2016-07-18
  • Event Date Posted
    2016-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148955
  • 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
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Reason
    Firm received customer complaints where end users reported that nomad pro and pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack pcb.
  • Action
    The firm sent a "FIELD ACTION NOTICE" to all affected customers.

Device

Device Recall NOMAD Pro Packaged XRay System
  • Model / Serial
    Part Number 08500009 - Serial Number Range BX-011008-01 - XB-141219049; Part Number 08500011- Serial Number Range XC -090305-03 - XC-140312-02; Part Number 08500013 - Serial Number Range XB-110411-01 - XB-140616-13; Part Number 08500017 - Serial Number Range XB-120911-04 - XB-141210-50; Part Number 08500019 - Serial Number Range XB-120517-09 - XB-121212-24
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA. HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY , Puerto Rico, Afghanistan, Argentina, Australia, Bahamas, Bahrain, Belgium, Bermuda, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kuwait, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Saudi Arabia, Papua New Guinea, Philippines, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Venezuela, Vietnam
  • Product Description
    NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019
  • Manufacturer
    Aribex Inc

Manufacturer

Aribex Inc
  • Manufacturer Address
    Aribex Inc, 11727 Fruehauf Dr, Charlotte NC 28273-6507
  • Manufacturer Parent Company (2017)
    Aribex
  • Source
    USFDA