DIGIMED CO., LTD recalls Portable X-ray system
Reason for recall
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Portable X-ray systemUDIModel Name
What the firm is doing
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.
DistributionShow detailsHide
US
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2117-2025
- FDA 510(k) clearance · K082167The device's official FDA premarket clearance record
- FDA device classification · EHDOfficial FDA classification for this device type
- CFR regulation · 21 CFR 872.1800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find DIGIMED CO., LTDSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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