Shimadzu, Trinias, Digital Angiography System
Recall
- Recall Number
- Z-1292-2024
- Event Number
- 93933
- Firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku
- FEI Number
- 3002808139
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- January 29, 2024
- Posted
- March 14, 2024
- Address
- 1 Kyoto Japan
Description
Shimadzu, Trinias, Digital Angiography System
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
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.
US Nationwide distribution in the states of OH.
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