Recall Z-0139-2025 ยท OWB Interventional Fluoroscopic X-Ray System
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
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.
| Date | Oct 22, 2024 (initiated Sep 6, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | On 9/6/24, recall notices were sent to customers who were asked to do the following: 1) Firmware for the system controller requires updating. The work to correct this issue will be performed by your Authorized Service provider. 2) Schedule time with your Distributer to have your system updated. 3) Complete and return the response form to drodriguez@shimadzu-usa.com Questions can be directed to the firm's National Technical Support: Toll Free: (844)487-2767 Available 8:00 to 5:00 PM, Monday - Friday |
| Quantity | 13 |
| Distribution | US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |