Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Widefield OCT software feature for the Spectralis HRA+OCT and variants Recalled by Heidelberg Engineering Due to FDA notified Heidelberg Engineering that a 510(k) clearance...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Heidelberg Engineering directly.
Affected Products
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Quantity: 382
Why Was This Recalled?
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.
Where Was This Sold?
Nationally
About Heidelberg Engineering
Heidelberg Engineering has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report