Recall Z-0139-2025— SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Class II · Ongoing
Class II FDA medical device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, initiated 2024-09-06. It names one FDA 510(k) clearance: K123508. Product: 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: 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..
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-06
- Firm location
- Kyoto, N/A, Japan
510(k) clearances named in this recall
1 on FDA's recordK-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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.