FDA Medical devices recall ·
Portable X-ray system recall
- Recall number
- Z-2117-2025
- Date
- (initiated June 19, 2025)
- Company / brand
- Digimed CO., Ltd
401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu, Seoul, N/A, Korea (the Republic of) - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 530
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Portable X-ray system
Why was it recalled?
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI/Model Name: 08800021800014/DIOX-602
Distribution
US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2117-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.