Z-1203-2023 Class II Ongoing
FDA device recall Z-1203-2023 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: 7 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
- 7 units
Product Description
Phoenix mKDR Xpress, 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 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208