# FDA recall Z-0697-2021

> **Haag-Streit USA Inc** · Class II · device recall initiated 2020-11-20.

## Product

Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515)  in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

## Reason for recall

Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by  pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye

## Distribution

US Nationwide distribution in the state of OK.

## Key facts

- **Recall number:** Z-0697-2021
- **Recalling firm:** Haag-Streit USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-20
- **Report date:** 2020-12-30

- **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-0697-2021

## Citation

> AI Analytics. FDA recall Z-0697-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0697-2021. Source: US FDA. Licensed CC0.

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