SEDECAL SA: Phoenix mKDR, digital mobile diagnostic x-ray system

Hazard

Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.

Details from the source

Reason for recall: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. Distribution: US, Argentina, Panama Quantity: 53 units Lot/code info: 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

UPC codes

08436046003002

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.