FDA recall Z-1203-2023
SEDECAL SA · Class II · device
Product
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
US, Argentina, Panama
Key facts
- Status
- Ongoing
- Initiation date
- 2023-02-06
- Report date
- 2023-03-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Algete, N/A, Spain
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1203-2023