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Recall Observatory FDA recall evidence

Device 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.

Z-2390-2015

July 13, 2015

Class II

Product summary

Firm
Sedecal S.A.
Event
Event 71714
Status
Terminated
Classification
Class II
Quantity
361 systems (U.S.); 5 systems (Foreign)
Official record key
device-enforcement:Z-2390-2015

Official wording

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.

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

Distribution pattern: Distributed US (nationwide) and in Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.