SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: Medical Device Recall in 2024 - (Recall #: Z-0139-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.

Product Classification:

Class II

Date Initiated: September 6, 2024

Date Posted: October 30, 2024

Recall Number: Z-0139-2025

Event ID: 95406

Reason for Recall:

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

Status: Ongoing

Product Quantity: 13

Code Information:

UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.

Distribution Pattern:

US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.

Voluntary or Mandated:

Voluntary: Firm initiated