FDA-Device2026-09-30Class IIPACKAGING DEFECT

Heidelberg Engineering SPECTRALIS imaging platform recalled for loose wheels and tip-over risk

OTHERNationwide distributionMedical devices

What this means

The wheels on Heidelberg Engineering's SPECTRALIS imaging device may come loose when the module is pushed or pulled during movement or transportation. If wheels loosen, the stand can become unstable and tip over, potentially causing impact or crushing injuries to nearby people.

Stop using the device immediately if you notice any loose or unstable wheels.
Contact Heidelberg Engineering for inspection and repair of your device.
Keep the area around the device clear of people while it remains in use.
Check the lot code on your device against the affected list provided by the manufacturer.

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

Manufactured in

Max-Jarecki-Str. 8, Heidelberg, Germany

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3215-2026

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