Seoul, N/A, Korea (the Republic of)
DIGIMED CO., LTD recalls
1 recall recorded since 2018, most recently on 19 June 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 June 2025
- Reason
- Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
- Distribution
- US
- Initiated
- FDA Mandated
- Recall number
- Z-2117-2025
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.