FDA recall Z-2117-2025
DIGIMED CO., LTD · Class II · device
Product
Portable X-ray system
Reason for recall
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Distribution
US
Key facts
- Status
- Ongoing
- Initiation date
- 2025-06-19
- Report date
- 2025-07-30
- Voluntary/Mandated
- FDA Mandated
- Location
- Seoul, N/A, Korea (the Republic of)
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2117-2025