Z-1202-2023 Class II Ongoing
FDA device recall Z-1202-2023 was initiated by SEDECAL SA on February 6, 2023 and is designated Class II. Reason for recall: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. The recall status is ongoing. Affected quantity: 53 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- February 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 units
Product Description
Phoenix mKDR, digital mobile diagnostic x-ray system
Reason for Recall
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Distribution Pattern
US, Argentina, Panama
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