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U.S. Department of Health and Human Services

Class 2 Device Recall Virtual Imaging (A Canon U.S.A. Company)

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  Class 2 Device Recall Virtual Imaging (A Canon U.S.A. Company) see related information
Date Initiated by Firm July 13, 2015
Date Posted August 14, 2015
Recall Status1 Terminated 3 on February 20, 2018
Recall Number Z-2390-2015
Recall Event ID 71714
510(K)Number K101517  
Product Classification System, x-ray, mobile - Product Code IZL
Product RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray.

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
Code Information Serial numbers: G29393 , G29395 , G29404 , G29416 , G29426 , G29864 , G29873 , G29878 , G30025 , G30155 , G30156 , G30160 , G30165 , G30173 , G30236 , G30240 , G30250 , G30254 , G30258 , G30567 , G30570 , G30684 , G30689 , G30761 , G30762 , G30771 , G30808 , G30902 , G30952 , G30960 , G31065 , G31077 , G31252 , G31256 , G31259 , G31271 , G31285 , G31403 , G31412 , G31526 , G31761 , G32487 , G32498 , G32514 , G32577 , G32581 , G32584 , G32587 , G32657 , G32671 , G32753 , G32936 , G33004 , G33102 , G33103 , G33111 , G33112 , G33126 , G33127 , G33144 , G33212 , G33238 , G33309 , G33324 , G33333 , G33344 , G33581 , G33585 , G33634 , G33708 , G33711 , G33721 , G33723 , G35389 , G35422 , G35429 , G35430 , G35442 , G35450 , G35462 , G35480 , G35504 , G35524 , G35611 , G35620 , G35630 , G35641 , G35665 , G35718 , G36042 , G36137 , G36148 , G36206 , G36211 , G36217 , G36222 , G36227 , G36244 , G36272 , G36281 , G36287 , G36468 , G36492 , G36526 , G36537 , G36542 , G36566 , G36573 , G36581 , G36601 , G36626 , G36643 , G36681 , G36689 , G36732 , G36751 , G36761 , G37108 , G37119 , G37129 , G37158 , G37168 , G37188 , G37196 , G37209 , G37234 , G37239 , G37280 , G37293 , G37357 , G37359 , G37413 , G37422 , G37430 , G37442 , G37456 , G37466 , G37475 , G37490 , G37494 , G37501 , G37508 , G37528 , G37536 , G37587 , G37588 , G37641 , G37646 , G37678 , G38058 , G38060 , G38069 , G38076 , G38082 , G38173 , G38178 , G38190 , G38198 , G38272 , G38279 , G38292 , G38293 , G38385 , G38391 , G38613 , G38629 , G38635 , G38643 , G38652 , G38657 , G38666 , G38711 , G38712 , G39465 , G39467 , G39518 , G39533 , G39551 , G39588 , G39589 , G39639 , G39650 , G39657 , G39782 , G39791 , G39800 , G39801 , G39808 , G39809 , G39818 , G39822 , G40016 , G40024 , G40025 , G40116 , G40120 , G40124 , G40126 , G40185 , G40186 , G40190 , G40196 , G40199 , G40203 , G40211 , G40216 , G40227 , G40590 , G40989 , G41058 , G41066 , G41083 , G41098 , G41100 , G41104 , G41108 , G41109 , G41114 , G41119 , G41143 , G41163 , G41192 , G41203 , G41213 , G41218 , G41222 , G41234 , G41244 , G41245 , G41256 , G41267 , G60058 , G60061 , G60062 , G60063 , G60064 , G60065 , G60066 , G60067 , G60069 , G60070 , G60166 , G60169 , G60400 , G60406 , G60415 , G60418 , G60429 , G60430 , G60431 , G60432 , G60435 , G60461 , G60518 , G60520 , G60576 , G60577 , G60582 , G60597 , G60606 , G60631 , G60635 , G60652 , G61307 , G61311 , G61333 , G61337 , G61339 , G61356 , G61367 , G61368 , G61393 , G61394 , G61698 , G61702 , G61706 , G61707 , G61711 , G61715 , G61716 , G61720 , G61725 , G61726 , G61786 , G61795 , G61804 , G61812 , G61814 , G61818 , G61867 , G61872 , G61873 , G61880 , G62011 , G62012 , G62015 , G62020 , G62029 , G62030 , G62037 , G62053 , G62059 , G62062 , G62066 , G62500 , G62502 , G62511 , G62558 , G62564 , G62565 , G62566 , G62626 , G62660 , G62662 , G62682 , G62684 , G62687 , G62747 , G62750 , G62762 , G62804 , G62814 , G62821 , G62828 , G62860 , G62863 , G62867 , G62883 , G62891 , G62892 , G62900 , G62938 , G62943 , G63212 , G63318 , G63328 , G63333 , G63495 , G64500 , G64510 , G64512 , G64789 , G64807 , G64813 , G64854 , G64855 , G64883 , G64891 , G64941 , G65043 , G65172 , G65266 , G65269 , G65275 , G65281 , G65281 , G65289 , G65290 , G65393 , G65395 , G65588 , G65691 , G65692 , G66862 , G66872 , G67257
Recalling Firm/
Manufacturer		 Sedecal S.A.
C/Pelaya, 9-13
Pol. Industrial Rio De Janiero
Algete Spain
For Additional Information Contact Mr. Jose Conceicao
561-893-8400
Manufacturer Reason
for Recall		 Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient.
FDA Determined
Cause 2		 Device Design
Action FIELD CORRECTION NOTIFICATION letters dated July 13, 2015 were sent to all dealers. The letters instructed the dealers: to schedule the replacement of the current arrestor by a new design of resistive arrestor with a resistance of 1 M ohm between frame and floor (ground). Although the metallic arrestor is only implemented in the equipments manufactured from April 2013 till March 2015, the upgrade kit has to be implemented in all the installed base of Mobiles with the same configuration in order to ensure that even the arrestors installed as spare part are replaced. Sedecal will provide the necessary upgrade kits to all the customers or distributors. *** U.S. Distributor, Virtual Imaging (a Canon U.S.A. Company) will use letter entitled, FIELD CORRECTION NOTIFICATION, RADPRO 40kW - -DIGITAL MOBILE X-RAY SYSTEM and dated 7/13/2015 to communicate to end users. The letter states "Once Virtual Imaging receives the resistive arrestor, we will contact you to schedule the replacement on the Affected System that you service." Please contact Virtual Imaging, Inc.'s Technical Support for any questions at 561.893.8500 or technicalsupport@vifla.com. ****
Quantity in Commerce 361 systems (U.S.); 5 systems (Foreign)
Distribution Distributed US (nationwide) and in Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SEDECAL S.A.
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