Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements
SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.
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: This is an FDA Class II recall involving a medical device with 3 documented incidents of erratic movement. No injuries, hospitalizations, or property damage are reported in the source. Per the severity rubric, this qualifies as 'High' because it represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
SEDECAL SA is recalling 53 units of the Phoenix mKDR, a mobile diagnostic x-ray system. The recall was initiated following 3 reported incidents involving erratic movements of the device.
The affected units were distributed in the United States, Argentina, and Panama. They can be identified by their UDI (Unique Device Identifier) and specific serial numbers provided by the FDA.
Facilities and practitioners using this equipment should check whether they have any of the affected serial numbers. Those with recalled units should discontinue use and contact the manufacturer for further instructions regarding repair or replacement options.
The recalled product
- Product
- Phoenix mKDR, 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 (20)
- UDI/DI 08436046003002
- Serial Numbers: PH00092
- PH00093
- PH00094
- PH00095
- PH00097
- PH00098
- PH00099
- PH00100
- PH00110
- PH00111
- PH00112
- PH00113
- PH00114
- PH00115
- PH00116
- PH00117
- PH00118
- PH00135
- PH00136
Distribution
Distribution scope not specified by the agency.
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