SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku Shimadzu, Trinias, Digital Angiography System Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Shimadzu, Trinias, Digital Angiography System
Brand
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku
Lot Codes / Batch Numbers
Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
Products Sold
Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku is recalling Shimadzu, Trinias, Digital Angiography System due to Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026