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Open, Classified

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

FDA Recall Z-3215-2026 · Posted 2026-09-18

Recall StatusOpen, Classified
Product CodeOBO
Date Initiated2026-08-06
Product Quantity87

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.

Firm Action

Firm began notifying US customers on August 6, 2026 via email. Instruction to Customers: There is a possibility that the castor wheels of the Flex stand are not properly attached. The wheels may come loose when the Flex Module is being pulled or pushed during movement or transportation, affecting the stability of the stand. As a result, the Flex stand may tip over if not correctly handled or supported by the operator. Users shall schedule a service appointment with your Heidelberg Engineering service partner as soon as possible so that the castor fastenings can be inspected and, if necessary, corrected.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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