FDAClass IIFebruary 18, 2015

Digital Mobile X-ray Systems used to take diagnostic recall

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

Why was Digital Mobile X-ray Systems used to take diagnostic recalled?

There is a potential for unintended and erratic motion.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
Recalling firm
Virtual Imaging, Inc.
Quantity
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.
Recall date
February 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls