Recall Z-2117-2025— DIGIMED CO., LTD

Name: FDA recall Z-2117-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-19

Class II · Ongoing

Class II FDA medical device recall by DIGIMED CO., LTD, initiated 2025-06-19. It names one FDA 510(k) clearance: K082167. 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..

Recalling firm: DIGIMED CO., LTD
Classification: Class II
Status: Ongoing
Initiated: 2025-06-19
Firm location: Seoul, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K082167 — PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROXDigimed Corporation·cleared 2008-09-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.