Sedecal RadPro 40kW Digital X-Ray Panel Recalled for Uncontrolled Movement Risk
Sedecal S.A. is recalling RadPro 40kW Digital X-Ray systems because electrostatic energy may cause uncontrolled movements that could bump into users or patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (uncontrolled movement causing physical impact) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sedecal S.A. is recalling the RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray systems. The recall involves 361 systems in the United States and 5 systems in foreign markets, distributed nationwide in the US and in Canada. The devices are intended for use by qualified doctors or technicians for diagnostic radiographic exposures.
The recall is due to a potential hazard where electrostatic energy may be stored in the systems. This stored energy can cause a short-circuit, which may generate an electromagnetic pulse. Such a pulse could disturb the electronics of the Digital Motion Control Board, producing uncontrolled movements. These uncontrolled movements could cause the system to bump into the user or patient.
Affected units are identified by specific serial numbers listed in the recall documentation. Users should contact Sedecal S.A. for further instructions on how to address this issue.
The recalled product
- 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 ot
- Manufacturer
- Sedecal S.A.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: G29393
- G29395
- G29404
- G29416
- G29426
- G29864
- G29873
- G29878
- G30025
- G30155
- G30156
- G30160
- G30165
- G30173
- G30236
- G30240
- G30250
- G30254
- G30258
- G30567
Distribution
Distributed nationwide across the United States.
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