# FDA recall Z-3215-2026

> **Heidelberg Engineering GmbH** · Class II · device recall initiated 2026-08-06.

## Product

Brand Name: Heidelberg Engineering GmbH  Product Name: SPECTRALIS with Flex Module  Model/Catalog Number: S3610, S2610, S2000, S1610    multimodal imaging platform optimized for the posterior segment of the eye

## Reason for recall

Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.

## Distribution

Worldwide - US Nationwide distribution in the state of Massachusetts and the countries of Australia, Costa Rica, Germany, France, India, Israel, Italy, Canada, Mexico, Netherlands, Austria, Philippines, Poland, Saudi Arabia, Switzerland, Spain. South Africa. Thailand, Czech Republic, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-3215-2026
- **Recalling firm:** Heidelberg Engineering GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-06
- **Report date:** 2026-09-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3215-2026

## Citation

> MORVS. FDA recall Z-3215-2026. Retrieved 2026-10-22 from https://api.morvs.ai/recall/Z-3215-2026. Source: US FDA. Licensed CC0.

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