# FDA recall Z-0182-2023

> **SEDECAL SA** · Class II · device recall initiated 2022-08-12.

## Product

Sedecal Soltus    Battery Mobile X-Ray System REF Soltus 450      Battery Mobile X-Ray System REF Soltus 500

## Reason for recall

Due to un-commanded movement of mobile x-ray unit.

## Distribution

U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX  O.U.S.: N/A

## Key facts

- **Recall number:** Z-0182-2023
- **Recalling firm:** SEDECAL SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-12
- **Report date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Algete, N/A, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2023

## Citation

> AI Analytics. FDA recall Z-0182-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0182-2023. Source: US FDA. Licensed CC0.

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