Shimadzu, Trinias, Digital Angiography System
FDA Recall Z-1292-2024 · Posted 2024-03-14
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Recalling FirmSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
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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