Heidelberg Engineering GmbH: Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 mult
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-08-06
- 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
- Product quantity
- 87
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Heidelberg
- Country
- Germany
- Event id
- 99595
Free daily digest + "My products" watchlist