# FDA recall Z-2437-2019

> **Heidelberg Engineering GmbH** · Class II · device recall initiated 2019-07-03.

## Product

SPECTRALIS with HEYEX2 image management system.   a non-contact ophthalmic diagnostic imaging device.

## Reason for recall

Error in the default configuration which could lead to the incorrect display of patient master data.

## Distribution

US nationwide distribution

## Key facts

- **Recall number:** Z-2437-2019
- **Recalling firm:** Heidelberg Engineering GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-03
- **Report date:** 2019-09-11
- **Termination date:** 2020-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Heidelberg, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2019

## Citation

> AI Analytics. FDA recall Z-2437-2019. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2437-2019. Source: US FDA. Licensed CC0.

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