Recall Z-1292-2024 ยท OWB Interventional Fluoroscopic X-Ray System
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Shimadzu, Trinias, Digital Angiography System
| Date | Mar 14, 2024 (initiated Jan 29, 2024) |
| Status | Open, Classified |
| Reason | Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function. |
| Root cause | Process change control |
| Action | On January 29, 2024, Shimadzu Medical Systems USA, issued a "Urgent Voluntary Medical Device Recall Notice to affected consignees. Shimadzu asked consignees to take the following actions: 1. Please check the list of systems affected by this recall. If your site is on the applicable list, please schedule time with your Distributer to have your system updated and calibrated. Shimadzu requests that you post this letter within your facility so that all users are aware that a recall has been issued. 2. Please pay attention to possible issue with images on your systems. If operation is deemed to |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the states of OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |