Z-1064-2015Class II

Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients

Name: Z-1064-2015 Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients
Creator: Virtual Imaging, Inc.
Published: 2014-09-22
License: https://open.fda.gov/license/

Virtual Imaging, Inc. / initiated 2014-09-22 / Terminated / root cause: design

FDA source

Virtual Imaging, Inc. began a recall of Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients on 2014-09-22. FDA classified it as Class II and gives the reason as "There is a potential for unintended and erratic motion". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1064-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-22
Posted: 2015-02-09
Terminated: 2018-02-20
Recalling firm: Virtual Imaging, Inc.
Product: Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
Product code: IZL System, X-Ray, Mobile
Reason for recall: There is a potential for unintended and erratic motion.
Root cause tag: design
FDA root cause: Component design/selection
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 [email protected].
Quantity in commerce: 316 (US) 6 (Foreign)
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1064-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1064-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-09

Product code IZL

K101517Class IISedecal Mobile Digital Diagnostic X-RaySedecal., Sa. / cleared 2011-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)