# FDA recall Z-1083-2024

> **SEDECAL SA** · Class II · device recall initiated 2021-10-14.

## Product

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

## Reason for recall

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button.  This would result in the system moving on its own in a very slow speed forward circular motion.

## Distribution

US Nationwide distribution. There was government distribution but no military distribution.

## Key facts

- **Recall number:** Z-1083-2024
- **Recalling firm:** SEDECAL SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-14
- **Report date:** 2024-02-21

- **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-1083-2024

## Citation

> AI Analytics. FDA recall Z-1083-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1083-2024. Source: US FDA. Licensed CC0.

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