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U.S. Department of Health and Human Services

Class 2 Device Recall Shimadzu, Trinias, Digital Angiography System

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 Class 2 Device Recall Shimadzu, Trinias, Digital Angiography Systemsee related information
Date Initiated by FirmJanuary 29, 2024
Date PostedMarch 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1292-2024
Recall Event ID 93933
510(K)NumberK123508 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductShimadzu, Trinias, Digital Angiography System
Code Information Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
Recalling Firm/
Manufacturer		 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Nishinokyo Kuwabara -Cho
Nakagyo-Ku; 1
Kyoto Japan
For Additional Information ContactMr. Johnny Goossens
310-2178855 Ext. 130
Manufacturer Reason
for Recall		Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
FDA Determined
Cause 2		Process change control
ActionOn 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.
Quantity in Commerce1
DistributionUS Nationwide distribution in the states of OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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