Devices

Device Recall DRX Revolution Mobile XRay System

  • Model / Serial
    Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.
  • Product Description
    DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 || Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 || The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
  • Manufacturer
    Carestream Health, Inc.
  • 1 Event

Manufacturer

Carestream Health, Inc.
  • Manufacturer Address
    Carestream Health, Inc., 150 Verona Street, Rochester NY 14608-1733
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall DRX Revolution Mobile Xray System
  • Model / Serial
    Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.
  • Product Description
    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). || The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
  • Manufacturer
    Carestream Health Inc.
Device Recall DRX Revolution Mobile Xray System
  • Model / Serial
    Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.
  • Product Description
    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 || to perform radiographic x-ray examinations on all pediatric and adult patients
  • Manufacturer
    Carestream Health Inc.