FDA Device recall Z-3215-2026

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimod…

• FDA Device
• Class II
• ongoing
• Published 2026-09-30

On 2026-09-30 the FDA classified a Class II recall of Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimod… by Heidelberg Engineering, citing 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….

Read the official FDA Device notice

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

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.

Other recalls by Heidelberg Engineering

• SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device
  FDA Device · Class II · 2019-09-11 · Heidelberg Engineering
• Widefield OCT software feature for the Spectralis HRA+OCT and variants
  FDA Device · Class II · 2018-05-02 · Heidelberg Engineering

All Heidelberg Engineering recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3215-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.