Device product
Phoenix mKDR, digital mobile diagnostic x-ray system
Z-1202-2023
Product summary
- Firm
- SEDECAL SA
- Event
- Event 91656
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 units
- Official record key
device-enforcement:Z-1202-2023
Official wording
Reason: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Code information: UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091
Distribution pattern: US, Argentina, Panama
Derived failure modes
-
Unknown
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.