# FDA recall Z-0655-2022

> **Shimadzu Medical Systems** · Class II · device recall initiated 2021-12-16.

## Product

Digital Angiography System Shimadzu Trinias     Generator Model: D150GC-40

## Reason for recall

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

## Distribution

U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA     O.U.S.: Not provided.

## Key facts

- **Recall number:** Z-0655-2022
- **Recalling firm:** Shimadzu Medical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-16
- **Report date:** 2022-03-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2022

## Citation

> AI Analytics. FDA recall Z-0655-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0655-2022. Source: US FDA. Licensed CC0.

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