FDA Medical Device Recalls (openFDA)
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: Shimadzu, Trinias, Digital Angiography System
- Recall number
- Z-1292-2024
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Product
- Shimadzu, Trinias, Digital Angiography System
- Status
- Open, Classified
- Initiated
- 2024-01-29
- Posted
- 2024-03-14
- Terminated
- not on file
- Reason
- Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
- 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
- 1
- Distribution
- US Nationwide distribution in the states of OH.
- Lot, serial or model codes
- Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
- 510(k) numbers
- ["K123508"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3002808139
- Firm city
- Kyoto
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28