RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray — Class II medical device recall Z-2390-2015
Terminated recall by Sedecal S.A., reported 2015-08-26, distributed nationwide. Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an El
| Recall number | Z-2390-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sedecal S.A., Algete, Spain |
| Recall initiated | 2015-07-13 |
| Classified | 2015-08-14 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2018-02-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| 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 and 340 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2390-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.