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Recall Observatory FDA recall evidence

Device product

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

Z-1064-2015

September 22, 2014

Class II

Product summary

Firm
Virtual Imaging, Inc.
Event
Event 69388
Status
Terminated
Classification
Class II
Quantity
316 (US) 6 (Foreign)
Official record key
device-enforcement:Z-1064-2015

Official wording

Reason: There is a potential for unintended and erratic motion.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for unintended and erratic motion.