Class II — Heidelberg Engineering
| Recalling firm | Heidelberg Engineering GmbH |
|---|---|
| Registered facility | HEIDELBERG ENGINEERING GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature. |
| Product | Widefield OCT software feature for the Spectralis HRA+OCT and variants |
| Quantity | 382 |
| Distribution | Nationally |
| Initiated | 2017-12-08 |
| Classified | 2018-04-26 |
| Terminated | 2020-06-04 |
| Recall number | Z-1535-2018 |
| 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 (Z-1535-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79453/
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