# FDA recall Z-2060-2018

> **Shimadzu Medical Systems** · Class II · device recall initiated 2018-01-12.

## Product

Sonialvision Safire II, Model #: DAR-8000f     Product Usage:  This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

## Reason for recall

When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the  pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray  Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.

## Distribution

US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.

## Key facts

- **Recall number:** Z-2060-2018
- **Recalling firm:** Shimadzu Medical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-06-20
- **Termination date:** 2022-02-24

- **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-2060-2018

## Citation

> AI Analytics. FDA recall Z-2060-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2060-2018. Source: US FDA. Licensed CC0.

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