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U.S. Department of Health and Human Services

Class 2 Device Recall TRINIAS

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 Class 2 Device Recall TRINIASsee related information
Date Initiated by FirmSeptember 06, 2024
Date PostedOctober 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0139-2025
Recall Event ID 95406
510(K)NumberK123508 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductTrinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Code Information UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
FEI Number 3002808139
Recalling Firm/
Manufacturer		 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Nishinokyo Kuwabara -Cho
Nakagyo-Ku; 1
Kyoto Japan
For Additional Information Contact
8175823-1305
Manufacturer Reason
for Recall		If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
FDA Determined
Cause 2		Software Design Change
ActionOn 9/6/24, recall notices were sent to customers who were asked to do the following: 1) Firmware for the system controller requires updating. The work to correct this issue will be performed by your Authorized Service provider. 2) Schedule time with your Distributer to have your system updated. 3) Complete and return the response form to drodriguez@shimadzu-usa.com Questions can be directed to the firm's National Technical Support: Toll Free: (844)487-2767 Available 8:00 to 5:00 PM, Monday - Friday
Quantity in Commerce13
DistributionUS Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
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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