Recall Z-3215-2026— Heidelberg Engineering GmbH

Name: FDA recall Z-3215-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-06

Class II · Ongoing

Class II FDA medical device recall by Heidelberg Engineering GmbH, initiated 2026-08-06. It names one FDA 510(k) clearance: K181594. 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..

Recalling firm: Heidelberg Engineering GmbH
Classification: Class II
Status: Ongoing
Initiated: 2026-08-06
Firm location: Heidelberg, Germany

510(k) clearances named in this recall

1 on FDA's record

K181594 — Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH·cleared 2018-09-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.