CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
Portable X-ray system recalled by Digimed Co
Digimed is recalling Portable X-ray system. The recall was initiated on 19 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2117-2025
- FDA event ID
- 97270
- Recalling firm
- Digimed, Seoul, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Jun 2025
- FDA classified
- 18 Jul 2025
- Reported
- 30 Jul 2025
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 19 Jun 2025 | Recall initiated by company | |
| 18 Jul 2025 | Classified by FDA | +29 days |
| 30 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Product as listed by the FDA
Portable X-ray system
Where it was distributed
US
Questions about this recall
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.
Which lots are affected?
UDI-DI/Model Name: 08800021800014/DIOX-602
Where was it sold?
US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |