# FDA recall Z-0781-2024

> **SEDECAL SA** · Class II · device recall initiated 2023-12-13.

## Product

Sedecal X Optima URS digital mobile diagnostic x-ray system.      A a stationary x-ray unit with a universal swivel arm.  It allows one to take exposures of patients in standing, sitting, or laying position.

## Reason for recall

Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

## Distribution

Distribution was made to AL, FL, and NC.  There was no military/government distribution.

## Key facts

- **Recall number:** Z-0781-2024
- **Recalling firm:** SEDECAL SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-13
- **Report date:** 2024-01-31

- **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-0781-2024

## Citation

> AI Analytics. FDA recall Z-0781-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0781-2024. Source: US FDA. Licensed CC0.

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