FDA Device recall Z-1535-2018
Widefield OCT software feature for the Spectralis HRA+OCT and variants
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Widefield OCT software feature for the Spectralis HRA+OCT and variants by Heidelberg Engineering, citing 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 5….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1535-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-08 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Heidelberg Engineering |
| Distribution | n/a |
Product
Widefield OCT software feature for the Spectralis HRA+OCT and variants
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.
Identifiers
| code_info | The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only us…The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only usable with the Widefield Objective Module accessory and a dedicated license. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1535-2018%22
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