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
- Recall Number
- Z-0864-2019
- Event Number
- 82002
- Firm
- Shimadzu Medical Systems Usa Com
- FEI Number
- 1000125362
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 14, 2019
- Terminated
- April 30, 2021
- Address
- 20101 S Vermont Ave, Torrance, CA, 90502-1328
Description
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.
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.
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.
FL, MT, CT, OH, IL, TX, MS, LA, SC
13 units