Device recall
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
- Recall number
- Z-3215-2026
- Event id
- 99595
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Heidelberg Engineering GmbH
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 6, 2026
- Center classification date
- Sep 18, 2026
- Product code
- OBO
- Device type
- Tomography, Optical Coherence
- 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
- Quantity
- 87
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K181594
- Location
- Heidelberg, Germany