# FDA recall Z-0554-2021

> **Shimadzu Medical Systems** · Class II · device recall initiated 2020-11-18.

## Product

Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

## Reason for recall

The firm has identified a problem with the control software for the celling arm of the X-Ray System .  This software issue could cause the  ceiling arm of the device to move after the operator has released the  movement lever. This could result in possible collision or harm to the patient or system operator.

## Distribution

US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.

## Key facts

- **Recall number:** Z-0554-2021
- **Recalling firm:** Shimadzu Medical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-18
- **Report date:** 2020-12-16

- **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-0554-2021

## Citation

> AI Analytics. FDA recall Z-0554-2021. Retrieved 2026-08-20 from https://api.ai-analytics.org/recall/Z-0554-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*