FDA Medical Device Recalls (openFDA)
DIGIMED CO., LTD: Portable X-ray system
- Recall number
- Z-2117-2025
- Recalling firm
- DIGIMED CO., LTD
- Product
- Portable X-ray system
- Status
- Open, Classified
- Initiated
- 2025-06-19
- Posted
- 2025-07-18
- Terminated
- not on file
- Reason
- Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- 530
- Distribution
- US
- Lot, serial or model codes
- UDI-DI/Model Name: 08800021800014/DIOX-602
- 510(k) numbers
- ["K082167"]
- PMA numbers
- not on file
- Product code
- EHD
- Firm FEI
- 3007933232
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28