Official recall record
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 mult
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-08-06
- Country of alert
- Germany
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04059237000235
- Brand on record
- Heidelberg Engineering GmbH
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-22.
Record last checked against the registry on 2026-10-22.
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