# FDA recall Z-0864-2019

> **Shimadzu Medical Systems Usa Com** · Class II · device recall initiated 2019-01-14.

## 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.

## Reason for recall

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.

## Distribution

FL, MT, CT, OH, IL, TX, MS, LA, SC

## Key facts

- **Recall number:** Z-0864-2019
- **Recalling firm:** Shimadzu Medical Systems Usa Com
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-14
- **Report date:** 2019-02-27
- **Termination date:** 2021-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Torrance, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0864-2019

## Citation

> AI Analytics. FDA recall Z-0864-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0864-2019. Source: US FDA. Licensed CC0.

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