Z-2390-2015Class II

RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained...

Name: Z-2390-2015 RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained...
Creator: Sedecal S.A.
Published: 2015-07-13
License: https://open.fda.gov/license/

Sedecal S.A. / initiated 2015-07-13 / Terminated / root cause: design

FDA source

Sedecal S.A. began a recall of 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... on 2015-07-13. FDA classified it as Class II and gives the reason as "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...". 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-2390-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-13
Posted: 2015-08-14
Terminated: 2018-02-20
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.
Product code: IZL System, X-Ray, Mobile
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.
Root cause tag: design
FDA 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 [email protected]. ****
Quantity in commerce: 361 systems (U.S.); 5 systems (Foreign)
Distribution: Distributed US (nationwide) and in Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2390-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2390-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)