Z-2117-2025Class II

Portable X-ray system

Name: Z-2117-2025 Portable X-ray system
Creator: Digimed Co., Ltd
Published: 2025-06-19
License: https://open.fda.gov/license/

Digimed Co., Ltd / initiated 2025-06-19 / Open, Classified

FDA source

DIGIMED CO., LTD began a recall of Portable X-ray system on 2025-06-19. FDA classified it as Class II and gives the reason as "Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2117-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-19
Posted: 2025-07-18
Recalling firm: Digimed Co., Ltd
Product: Portable X-ray system
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 530
Distribution: US
Product codes and lots: UDI-DI/Model Name: 08800021800014/DIOX-602

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2117-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2117-2025	Class II	Ongoing	FDA Mandated	2025-07-30	2025-07-18

Product code EHD

K082167Class IIPortable X-Ray System, Models Diox-602, ProxDigimed Corporation / cleared 2008-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)