# FDA recall Z-0478-2022

> **Haag-Streit USA Inc** · Class II · device recall initiated 2021-11-03.

## Product

OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

## Reason for recall

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

## Distribution

US Nationwide distribution in the states of OH, IN.

## Key facts

- **Recall number:** Z-0478-2022
- **Recalling firm:** Haag-Streit USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-03
- **Report date:** 2022-01-19

- **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-0478-2022

## Citation

> AI Analytics. FDA recall Z-0478-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0478-2022. Source: US FDA. Licensed CC0.

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