Heidelberg Engineering GmbH recalls Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610,
Heidelberg Engineering recalls SPECTRALIS with Flex Module models S3610, S2610, S2000, S1610 due to wheels potentially coming loose during use, which could cause the stand to tip over and injure users.
Use caution until it’s fixed
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.
What happened, in plain English
Heidelberg Engineering is recalling SPECTRALIS with Flex Module devices (models S3610, S2610, S2000, S1610) because wheels may become loose during movement or transportation, risking tipping over and causing injuries to the operator or nearby people. Read more at govinfonow.com/recall/1292653-heidelberg-engineering-spectralis-with-flex-module-recall-risk-of-stand.
Source Summary by GovInfoNow · govinfonow.com/recall/1292653-heidelberg-engineering-spectralis-with-flex-module-recall-risk-of-stand · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3215-2026
Cite this page
“Heidelberg Engineering SPECTRALIS with Flex Module Recall: Risk of Stand Tipping Over.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292653-heidelberg-engineering-spectralis-with-flex-module-recall-risk-of-stand. Based on FDA recall #Z-3215-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3215-2026%22&limit=1).
Why it’s dangerous
The wheels on the stand can become loose when the module is pushed or pulled during movement or transportation. This instability may cause the stand to tip over, potentially leading to impact or crushing injuries to the operator's feet, legs, hands, or arms, or those nearby.
Who’s affected
Users of the SPECTRALIS with Flex Module for eye imaging who operate the device during medical procedures are most at risk. This includes healthcare professionals using the equipment in clinical settings.
How to tell if you have this one
Check for the model numbers S3610, S2610, S2000, or S1610 on the device. The product is a multimodal imaging platform for eye imaging, sold with specific lot codes listed in the recall notice.
- Brand
Heidelberg Engineering- Category
Medical device
What to do — step by step
Check for Loose Wheels
Inspect the wheels for looseness when pushing or pulling the module during movement or transportation.
Secure the Stand
Ensure the stand is properly anchored to prevent tipping during use.
Questions people ask
What models are affected by this recall?
The affected models are S3610, S2610, S2000, and S1610.
Why is this recall happening?
The wheels may come loose during movement or transportation, which could cause the stand to tip over and lead to injuries.
How can I tell if my device is affected?
Check for the model numbers S3610, S2610, S2000, or S1610 on the device. The product is a multimodal imaging platform for eye imaging.
Contact Heidelberg Engineering
We’ve drafted a message you can send Heidelberg Engineering to request your refund or repair — edit it as you like.
Subject: Recall Z-3215-2026 — Heidelberg Engineering Heidelberg Engineering Hello, I own a Heidelberg Engineering that is covered by recall Z-3215-2026 from Heidelberg Engineering. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3215-2026 (August 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3215-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.