Heidelberg Engineering SPECTRALIS with Flex Module
The Spectralis with Flex Module imaging platform can tip over when wheels come loose, causing impact or crushing injuries.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Heidelberg Engineering GmbH is recalling the SPECTRALIS with Flex Module multimodal imaging platform, models S3610, S2610, S2000, and S1610, because the wheels may come loose when the module is pushed or pulled during movement or transportation, affecting the stability of the stand.
The stand may tip over, and a falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons. The recall began on August 6, 2026, and was added to the FDA's Enforcement Report on September 18, 2026.
The product was distributed in Massachusetts and worldwide, including countries such as Australia, Germany, France, and the United Kingdom.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number is listed.
SPECTRALIS with Flex Module
- Model
- S3610
- S2610
- S2000
- S1610
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99595
- Recall No.
- Z-3215-2026
- Company
- Heidelberg Engineering GmbHHeidelberg, Germany
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
