Z-0139-2025 Class II Ongoing
FDA device recall Z-0139-2025 was initiated by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION on Sep 6, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 13.
Recall details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
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.
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.
Distribution pattern
US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
Code information
UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0139-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026