# FDA recall Z-0867-2022

> **Shimadzu Medical Systems** · Class II · device recall initiated 2022-01-10.

## Product

MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

## Reason for recall

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

## Distribution

U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV.    O.U.S.: N/A

## Key facts

- **Recall number:** Z-0867-2022
- **Recalling firm:** Shimadzu Medical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-10
- **Report date:** 2022-04-13

- **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-0867-2022

## Citation

> AI Analytics. FDA recall Z-0867-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0867-2022. Source: US FDA. Licensed CC0.

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