Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2390-2015 — 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.

U.S. FDA — Device Enforcement · Spain · 2015-07-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2390-2015
Date of alert
2015-07-13
Country / jurisdiction
Spain
Risk level
Class II
Risk type
recall
Brand
Sedecal S.A.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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