Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610,
Summary
The FDA issued a Class II for Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Modu by Heidelberg Engineering GmbH. Reason: Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip ove.
Details
Source
Device Recall
External ID
Z-3215-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI-DI 04059237000235 Lot Code: Spec-07265, Spec-11121, Spec-11281, Spec-12096, Spec-13305, Spec-14403, Spec-15282, Spec-15587, Spec-20071, Spec-20348, Spec-20351, Spec-20591, Spec-20605, Spec-23473, Spec-23941, Spec-23950, Spec-23975, Spec-24507, Spec-24558, Spec-24582, Spec-24611
Quantity Affected: 87
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-06
Company
Heidelberg
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Heidelberg Engineering GmbH has 10 FDA actions in our database, including 1 recall and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heidelberg Engineering GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heidelberg Engineering GmbH have FDA actions?
Heidelberg Engineering GmbH has 10 FDA actions in our database, including 1 recall and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3215-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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