Portable X-ray System (Digimed) – Minimum Distance Concern (2025)
Some portable X-ray units may not meet minimum distance requirements.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Portable X-ray system
Brand
DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)
Lot Codes / Batch Numbers
UDI-DI/Model Name: 08800021800014/DIOX-602
Products Sold
UDI-DI/Model Name: 08800021800014/DIOX-602
DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of) is recalling Portable X-ray system due to Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Recommended Action
Per FDA guidance
DIGIMED Co., Ltd. sends Field Safety Notice / Urgent Device Correction, notifying customers of the Issue, Potential Risk, Required Customer Actions with Customer Acknowledgment Form with Return Instructions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026