DIGIMED CO., LTD: Medical Device Recall in 2025 - (Recall #: Z-2117-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Portable X-ray system

Product Classification:

Class II

Date Initiated: June 19, 2025

Date Posted: July 30, 2025

Recall Number: Z-2117-2025

Event ID: 97270

Reason for Recall:

Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

Status: Ongoing

Product Quantity: 530

Code Information:

UDI-DI/Model Name: 08800021800014/DIOX-602

Distribution Pattern:

Voluntary or Mandated:

FDA Mandated