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Open, Classified

Shimadzu, Trinias, Digital Angiography System

FDA Recall Z-1292-2024 · Posted 2024-03-14

Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2024-01-29
Product Quantity1

Reason for Recall

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

Firm 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 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

Distribution Pattern

US Nationwide distribution in the states of OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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