# FDA recall Z-2482-2019

> **Haag-Streit USA Inc** · Class II · device recall initiated 2019-07-31.

## Product

HS Hi-R NEO 900   Reference # 657 820  Serial # from 101    Product Usage:  A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.

## Reason for recall

software error in the central control unit of the floor stand.

## Distribution

US in the state of OH

## Key facts

- **Recall number:** Z-2482-2019
- **Recalling firm:** Haag-Streit USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-31
- **Report date:** 2019-09-11
- **Termination date:** 2020-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mason, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2019

## Citation

> AI Analytics. FDA recall Z-2482-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2482-2019. Source: US FDA. Licensed CC0.

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