Recall Z-3215-2026 ยท OBO Tomography, Optical Coherence
Heidelberg Engineering GmbH
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
| Date | Sep 18, 2026 (initiated Aug 6, 2026) |
| Status | Open, Classified |
| 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 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. |
| 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module Heidelberg Engineering GmbH, Sep 13, 2018 |