# FDA recall Z-0959-2019

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

## Product

BRANSIST safire    Product Usage:  DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.

## Reason for recall

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.

## Distribution

US Nationwide Distribution in the states of IN, OH, IL, SC

## Key facts

- **Recall number:** Z-0959-2019
- **Recalling firm:** Shimadzu Medical Systems Usa Com
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-14
- **Report date:** 2019-03-06
- **Termination date:** 2024-06-07

- **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-0959-2019

## Citation

> AI Analytics. FDA recall Z-0959-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0959-2019. Source: US FDA. Licensed CC0.

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