Franklin, MA, United States
Heidelberg Engineering GmbH recalls
3 recalls recorded since 2018, most recently on 6 August 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 August 2026
- 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.
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3215-2026
- 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
Terminated Class II Medical devices
- Recall started
- 3 July 2019
- Terminated
- 2 November 2020
- Reason
- Error in the default configuration which could lead to the incorrect display of patient master data.
- Distribution
- US nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2437-2019
- SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Terminated Class II Medical devices
- Recall started
- 8 December 2017
- Terminated
- 4 June 2020
- Reason
- FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1535-2018
- Widefield OCT software feature for the Spectralis HRA+OCT and variants
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.