Heidelberg Engineering recalls Spectralis HRA+OCT devices with Widefield OCT software feature until FDA 510(k) clearance is obtained. This software feature requires specific hardware and licensing.
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.
Heidelberg Engineering is recalling the Widefield OCT software feature for Spectralis HRA+OCT devices. The FDA requires this software feature to be cleared before it can be safely used, so users must stop using it until clearance is obtained.
The FDA requires specific 510(k) clearance for this software feature to ensure safety. Without clearance, the software may not function correctly during eye imaging procedures, potentially leading to inaccurate results.
Users of Spectralis HRA+OCT devices with Widefield OCT software feature (versions 6.3 to 6.8a) are affected. Medical professionals using this software for eye imaging are most at risk.
Check if your Spectralis HRA+OCT device has Widefield OCT software version 6.3 to 6.8a. This feature requires the Widefield Objective Module accessory and a dedicated license.
Immediately stop using the Widefield OCT software feature on your Spectralis device until FDA clearance is obtained.
The FDA requires specific 510(k) clearance for this software feature to ensure safety before it can be used. Heidelberg Engineering has not yet obtained this clearance.
The Widefield OCT software feature is affected in Spectralis HRA+OCT software versions 6.3 to 6.8a.
No, the device itself is not being recalled. Only the Widefield OCT software feature requires stopping use until clearance is obtained.
We’ve drafted a message you can send Heidelberg Engineering to request your refund or repair — edit it as you like.
Subject: Recall Z-1535-2018 — Heidelberg Engineering Heidelberg Engineering Hello, I own a Heidelberg Engineering that is covered by recall Z-1535-2018 from Heidelberg Engineering. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
