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

FDA Recall #Z-1535-2018 — Class II — December 8, 2017

Recall #Z-1535-2018 Date: December 8, 2017 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

Heidelberg Engineering — Franklin, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

382

Distribution

Nationally

Code Information

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

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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