Z-1292-2024Class II

Shimadzu, Trinias, Digital Angiography System

Name: Z-1292-2024 Shimadzu, Trinias, Digital Angiography System
Creator: Shimadzu Corporation Medical Systems Division
Published: 2024-01-29
License: https://open.fda.gov/license/

Shimadzu Corporation Medical Systems Division / initiated 2024-01-29 / Open, Classified / root cause: manufacturing process

FDA source

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION began a recall of Shimadzu, Trinias, Digital Angiography System on 2024-01-29. FDA classified it as Class II and gives the reason as "Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1292-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-29
Posted: 2024-03-14
Recalling firm: Shimadzu Corporation Medical Systems Division
Product: Shimadzu, Trinias, Digital Angiography System
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
Root cause tag: manufacturing process
FDA root cause: Process change control
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.
Quantity in commerce: 1
Distribution: US Nationwide distribution in the states of OH.
Product codes and lots: Serial Number: 41EFFF7D3001/UDI: (01)04540217058020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1292-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1292-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14

Product code OWB

K123508Class IITriniasShimadzu Corporation / cleared 2014-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)