FDA Medical Device Recalls (openFDA)
Shimadzu Medical Systems Usa Com: TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Recall number
- Z-0864-2019
- Recalling firm
- Shimadzu Medical Systems Usa Com
- Product
- TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Status
- Terminated
- Initiated
- 2019-01-14
- Posted
- not on file
- Terminated
- 2021-04-30
- Reason
- Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
- Root cause
- Software design
- Action
- The dealers by email on 01/14/2019 and the end users by mail on 01/15/2019. The letters to the end users explain the problem and a workaround. A service representative will contact the end user to schedule a software update.
- Quantity
- 13 units
- Distribution
- FL, MT, CT, OH, IL, TX, MS, LA, SC
- Lot, serial or model codes
- Serial Numbers: 41B247746001, 41B24774C001, 41E58C757001, 41E58C765001, 41E58C766001, 41E58C769001, 41E58C76B001, 41E58C773001, 41E58C775001, 41E58C776001, 41E58C777001, 41E58C977001, 41EFCD77C001
- 510(k) numbers
- ["K123508"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1000125362
- Firm city
- Torrance
- Firm state
- CA
- Firm country
- not on file
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