FDA Device recall Z-2390-2015
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray by Sedecal, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2390-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-13 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sedecal |
| Distribution | US |
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.
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.
Identifiers
| code_info | Serial numbers: G29393 , G29395 , G29404 , G29416 , G29426 , G29864 , G29873 , G29878 , G30025 , G30155 , G30…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 , G362 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2390-2015%22
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