# FDA recall Z-0488-2019

> **Sedecal S.A.** · Class II · device recall initiated 2018-07-18.

## Product

Sedecal NOVA FA DR System. for diagnostic radiography.

## Reason for recall

A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor.  Due to this, the equipment may fall and cause harm to the patient, user, or third parties.

## Distribution

US and Canada

## Key facts

- **Recall number:** Z-0488-2019
- **Recalling firm:** Sedecal S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-07-18
- **Report date:** 2018-11-28

- **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-0488-2019

## Citation

> AI Analytics. FDA recall Z-0488-2019. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0488-2019. Source: US FDA. Licensed CC0.

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