Z-3215-2026Class II

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number...

Name: Z-3215-2026 Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number...
Creator: Heidelberg Engineering GmbH
Published: 2026-08-06
License: https://open.fda.gov/license/

Heidelberg Engineering GmbH / initiated 2026-08-06 / Open, Classified

FDA source

Recall record

Recall number: Z-3215-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-06
Posted: 2026-09-18
Recalling firm: Heidelberg Engineering GmbH
Product: 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
Product code: OBO Tomography, Optical Coherence
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.
FDA root cause: Component design/selection
Action: Firm began notifying US customers on August 6, 2026 via email. Instruction to Customers: There is a possibility that the castor wheels of the Flex stand are not properly attached. The wheels may come loose when the Flex Module is being pulled or pushed during movement or transportation, affecting the stability of the stand. As a result, the Flex stand may tip over if not correctly handled or supported by the operator. Users shall schedule a service appointment with your Heidelberg Engineering service partner as soon as possible so that the castor fastenings can be inspected and, if necessary, corrected.
Quantity in commerce: 87
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3215-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3215-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code OBO

K181594Class IISpectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH / cleared 2018-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)