Heidelberg Engineering GmbH Product Name recall
Heidelberg Engineering GmbH recalled Heidelberg Engineering GmbH Product Name on September 30, 2026 because of wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. It was sold nationwide.
Why it was recalled
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's recalled
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
Quantity: 87
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Heidelberg Engineering GmbH, Heidelberg
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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… - Status
- Ongoing
- Recall number
- Z-3215-2026
- Source
- U.S. Food and Drug Administration
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