Urgent Field Safety Notice For Spectralis By Heidelberg Engineering Gmbh
Summary Heidelberg Engineering GmbH has issued a Class I safety notice for SPECTRALIS devices distributed in Germany and the EU. The notice addresses an urgent safety concern with the devices. This is the highest classification of safety alert for medical devices.
- Recalling firm
- Heidelberg Engineering GmbH
- Product
- SPECTRALIS
- Reason
- Urgent Field Safety Notice for SPECTRALIS by Heidelberg Engineering GmbH
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-07-24
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/a1bae724-c49d-43e6-a1df-be561ec39a1a