Shimadzu, Trinias, Digital Angiography System
FDA device recall Z-1292-2024 · posted 2024-03-14 · Open, Classified
Recall details
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Reason for recall
- Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
- Action taken
- 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 be non-standard then contact your local service representative so the issue can be investigated. 3. Shimadzu has identified the affected units and informed your authorized service representative. They will be contacting you to schedule a time to implement the corrective action. If you do not receive a call or visit concerning this matter, please contact Shimadzu National Support. 4. Please complete the Customer Acknowledgement receipt of letter form.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 1
- Distribution
- US Nationwide distribution in the states of OH.
- Date initiated
- 2024-01-29
- Date posted
- 2024-03-14
- Location
- Kyoto, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRINIAS (K123508) | Shimadzu Corporation | 2014-02-26 |