CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

Widefield OCT recalled by Heidelberg Engineering

Heidelberg Engineering is recalling Widefield OCT, distributed nationwide in the US. The recall was initiated on 8 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe 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.

Quantity recalled382

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1535-2018
FDA event ID: 79453
Recalling firm: Heidelberg Engineering, Franklin, MA
Classification: Class II
Status: Terminated
Recall initiated: 8 Dec 2017
FDA classified: 26 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

8 Dec 2017	Recall initiated by company
26 Apr 2018	Classified by FDA	+139 days
2 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Widefield OCT software feature for the Spectralis HRA+OCT and variants

Where it was distributed

Nationally

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

Nationally

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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