Events

Recall of Virtual Imaging RadPRO 40 kW

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Virtual Imaging, 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
    69388
  • Event Risk Class
    Class 2
  • Event Number
    Z-1064-2015
  • Event Initiated Date
    2014-09-22
  • Event Date Posted
    2015-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130399
  • 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
    System, x-ray, mobile - Product Code IZL
  • Reason
    There is a potential for unintended and erratic motion.
  • Action
    Virtual Imaging sent an FIELD CORRECTION NOTIFICATION letter dated September 22, 2014, to all affected customers. The letters advised direct accounts that a Virtual Imaging Field Engineer with contact them to schedule an appointment for the replacement of the Digital Motion Control Kit. Customers with any concerns about this situation can contact Virtual Imaging's Technical Support at 561-893-8500 or via e-mail at technicalsupport@vifla.com.

Device

Virtual Imaging RadPRO 40 kW
  • Model / Serial
    1) Model: MOBILE 32KW ANALOG; Serial Numbers: G29393 , G29395 , G29404 , G30236 , G30258 , G33309 , G33344 , G38069 , G38082 , G38711 , G38712 , G40196 , G40590 , G40989 , G41143 , G41163 , G60166 , G60169 , G60461 , G62020;  2) Model: MOBILE 40KW; Serial Numbers: G33126 , G35630 , G35641 , G35718 , G37357 , G31259;  3) Model: MOBILE 40KW 50G; Serial Numbers: G30684;  4) Model: MOBILE 40KW 55C; Serial Numbers: G37528;  5) Model: MOBILE 40KW 70C; Serial Numbers: G36211 , G36227 , G36281 , G36573 , G36581 , G36626 , G37168 , G38613 , G39518 , G40190 , G40227 , G60432 , G60435 , G60518 , G61367 , G61368 , G61720 , G61725 , G61726;  6) Model: MOBILE 40KW ANALOG; Serial Numbers: G30240;  7) Model: MOBILE2 40KW 50C; Serial Numbers: G31414 , G32487;  8) Model: MOBILE2 40KW 50G; Serial Numbers: G29416 , G29426 , G29824 , G29873 , G29878 , G30025 , G30155 , G30156 , G30160 , G30165 , G30173 , G30570 , G30685 , G30689 , G30761 , G30762 , G30767 , G30808 , G30952 , G31065 , G31067 , G31077 , G31403 , G31761 , G32577 , G32587 , G33004 , G33144 , G33581 , G33723 , G35450 , G35620;  9) Model: MOBILE2 40KW 55C; Serial Numbers: G32753 , G32764 , G33102 , G33111 , G33721 , G35462 , G35480;  10) Model: MOBILE2 40KW 55C/60C; Serial Numbers: G33585 , G37536;  11) Model: MOBILE2 40KW 55G; Serial Numbers: G32584 , G32949 , G33103 , G33127 , G33591 , G33646 , G33657 , G35422 , G35504;  12) Model: MOBILE2 40KW 55G/60G; Serial Numbers: G33711;  13) Model: MOBILE3 40KW; Serial Numbers: G41234 , G36566 , G38272;  14) Model: MOBILE3 40KW 55C; Serial Numbers: G37494 , G37501 , G37508 , G37587;  15) Model: MOBILE3 40KW 55C/60C; Serial Numbers: G35611 , G37490 , G37528 , G37588;  16) Model: MOBILE3 40KW 70C; Serial Numbers: 60597 , G36137 , G36148 , G36206 , G36217 , G36222 , G36244 , G36272 , G36287 , G36468 , G36492 , G36526 , G36537 , G36542 , G36601 , G36643 , G36681 , G36689 , G36732 , G36751 , G36761 , G37108 , G37111 , G37119 , G37129 , G37155 , G37158 , G37188 , G37196 , G37209 , G37234 , G37239 , G37293 , G37359 , G37413 , G37422 , G37430 , G37442 , G37442 , G37456 , G37466 , G37475 , G38058 , G38076 , G38173 , G38178 , G38190 , G38198 , G38279 , G38292 , G38293 , G38385 , G38391 , G38629 , G38635 , G38652 , G38657 , G39465 , G39467 , G39533 , G39551 , G39588 , G39589 , G39639 , G39650 , G39657 , G39782 , G39791 , G39800 , G39801 , G39808 , G39809 , G39818 , G40016 , G40024 , G40025 , G40116 , G40120 , G40124 , G40126 , G40185 , G40186 , G40199 , G40203 , G40211 , G40227 , G41058 , G41066 , G41083 , G41098 , G41098 , G41100 , G41104 , G41108 , G41109 , G41114 , G41119 , G41192 , G41203 , G41213 , G41218 , G41222 , G41244 , G41245 , G41256 , G60058 , G60061 , G60062 , G60063 , G60064 , G60065 , G60066 , G60069 , G-60069 , G60070 , G60406 , G60415 , G60418 , G60429 , G60430 , G60431 , G60520 , G60576 , G60577 , G60582 , G60606 , G60631 , G60635 , G60652 , G61307 , G61311 , G61333 , G61337 , G61339 , G61356 , G61393 , G61394 , G61698 , G61706 , G61715 , G61716 , G61786 , G61795 , G61812 , G61814 , G61818 , G61867 , G61872 , G61873 , G61880 , G62011 , G62012 , G62015 , G62029 , G62030 , G62037 , G62037 , G62053 , G62059 , G62062 , G62066 , G36042 , G37280 , G60400;  1)7 Model: MOBILE3 40KW 80C; Serial Numbers: G38060 , G39822 , G60067 , G61702;  18) Model: MOBILE3 40KW W/501C; Serial Numbers: G38666;  19) Model: RADPRO MOBILE; Serial Numbers: G29864 , G30250 , G30254 , G30567 , G30771 , G30902 , G30960 , G31252 , G31256 , G31271 , G31285 , G31287 , G31412 , G31480 , G31526 , G32218 , G32498 , G32514 , G32572 , G32581 , G32657 , G32671 , G33004 , G33103 , G33112 , G33126 , G33212 , G33238 , G33309 , G33324 , G33329 , G33333 , G-33634 , G33708 . G35389 , G35422 , G-35429 , G35430 , G35442 , G35524 , G35665
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in South Korea; and the country of Canada.
  • Product Description
    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
  • Manufacturer
    Virtual Imaging, Inc.

Manufacturer

Virtual Imaging, Inc.
  • Manufacturer Address
    Virtual Imaging, Inc., 5600 Broken Sound Blvd., 2nd Flr., Boca Raton FL 33487
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA