FDA Recalls Mobile X-Ray System for Erratic Movement Risk
SEDECAL's Phoenix mKDR Xpress mobile x-ray system is recalled due to three reported incidents of erratic movements. Seven units distributed in the US, Argentina, and Panama are affected.
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: FDA Class II recall with three documented incidents of equipment malfunction. No injuries or illnesses have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
SEDECAL SA has recalled the Phoenix mKDR Xpress, a digital mobile diagnostic x-ray system. Seven units with serial numbers PH00202 through PH00208 are affected by this recall.
The recall was initiated following three reported incidents of erratic movements in the x-ray mobile systems.
The affected units were distributed in the United States, Argentina, and Panama. Healthcare facilities and users with equipment bearing these serial numbers should contact SEDECAL SA or the FDA for further guidance.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
- Manufacturer
- SEDECAL SA
- Hazard
- erratic-movement
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 (8)
- UDI/DI 08436046003163
- Serial Numbers: PH00202
- PH00203
- PH00204
- PH00205
- PH00206
- PH00207
- PH00208
Distribution
Distribution scope not specified by the agency.
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