FDA Device recall Z-2117-2025
Portable X-ray system
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Portable X-ray system by Digimed, citing some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2117-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-19 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Digimed |
| Distribution | n/a |
Product
Portable X-ray system
Reason
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Identifiers
| code_info | UDI-DI/Model Name: 08800021800014/DIOX-602 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2117-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.