Class II — Heidelberg Engineering GmbH
| Recalling firm | Heidelberg Engineering GmbH |
|---|---|
| Registered facility | HEIDELBERG ENGINEERING GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Error in the default configuration which could lead to the incorrect display of patient master data. |
| Product | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. |
| Quantity | 29 |
| Distribution | US nationwide distribution |
| Initiated | 2019-07-03 |
| Classified | 2019-08-30 |
| Terminated | 2020-11-02 |
| Recall number | Z-2437-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Heidelberg Engineering GmbH (Z-2437-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83568/
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