Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
- Recall Initiated
- February 6, 2023
- Posted
- March 2, 2023
- Recall Number
- Z-1203-2023
- Quantity
- 7 units
Reason for Recall
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Distribution
US, Argentina, Panama
Lot / Code Info
UDI/DI 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208
Root Cause
Device Design
Action Taken
Sedecal issued an URGENT MEDICAL DEVICE RECALL notice to its US distributor on 02/06/2023 by email. The notice explained the issue and requested that distributor to warn its customers about the risk of potential erratic movement and provided a list of precautions until the software is installed. Questions may be directed to calidad-clientes@sedecal.com.