Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin
FDA device recall Z-0139-2025 · posted 2024-10-22 · Open, Classified
Recall details
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- 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.
- Action taken
- 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
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 13
- Distribution
- US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
- Date initiated
- 2024-09-06
- Date posted
- 2024-10-22
- Location
- Kyoto, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRINIAS (K123508) | Shimadzu Corporation | 2014-02-26 |