Summary
The FDA issued a Class II for Portable X-ray system by DIGIMED CO., LTD. Reason: Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm..
Details
Source
Device Recall
External ID
Z-2117-2025
Action Date
2025-07-30
Status
Ongoing
Category
device
Product Description
Portable X-ray system
Lot/Code Info: UDI-DI/Model Name: 08800021800014/DIOX-602
Quantity Affected: 530
Reason for Recall
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Distribution
US
Type: FDA Mandated
Recall Initiated: 2025-06-19
Company
Seoul, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DIGIMED CO., LTD has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DIGIMED CO., LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DIGIMED CO., LTD have FDA actions?
DIGIMED CO., LTD has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2117-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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