Device product
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Z-1203-2023
Product summary
- Firm
- SEDECAL SA
- Event
- Event 91656
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1203-2023
Official wording
Reason: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Code information: UDI/DI 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208
Distribution pattern: US, Argentina, Panama
Derived failure modes
-
Unknown
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.