Sedecal S.A.: 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.

Recall number

Z-2390-2015

Recalling firm

Sedecal S.A.

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.

Status

Terminated

Initiated

2015-07-13

Posted

2015-08-14

Terminated

2018-02-20

Reason

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.

Root cause

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

361 systems (U.S.); 5 systems (Foreign)

Distribution

Distributed US (nationwide) and in Canada.

Lot, serial or model codes

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

510(k) numbers

["K101517"]

PMA numbers

not on file

Product code

IZL

Firm FEI

3002495042

Firm city

Algete

Firm state

not on file

Firm country

Spain

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy