# FDA recall Z-1187-2019

> **Gyrus ACMI, Inc.** · Class II · device recall initiated 2019-03-08.

## Product

Diego Elite Malleable, 4mm Standard Monopolar  Blades  Product Code:MM4000SS

## Reason for recall

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

## Distribution

Nationwide  Foreign: Germany,Japan, Singapore

## Key facts

- **Recall number:** Z-1187-2019
- **Recalling firm:** Gyrus ACMI, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-08
- **Report date:** 2019-04-24
- **Termination date:** 2020-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bartlett, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1187-2019

## Citation

> AI Analytics. FDA recall Z-1187-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1187-2019. Source: US FDA. Licensed CC0.

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