# FDA recall Z-1535-2018

> **Heidelberg Engineering** · Class II · device recall initiated 2017-12-08.

## Product

Widefield OCT software feature for the Spectralis HRA+OCT and variants

## Reason for recall

FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature.   FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.

## Distribution

Nationally

## Key facts

- **Recall number:** Z-1535-2018
- **Recalling firm:** Heidelberg Engineering
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-08
- **Report date:** 2018-05-02
- **Termination date:** 2020-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2018

## Citation

> AI Analytics. FDA recall Z-1535-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1535-2018. Source: US FDA. Licensed CC0.

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