medical Class II Updated 2018-05-02

Heidelberg Engineering recalls Widefield OCT software feature for the Spectralis HRA+OCT an

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationally
Lot/Code Info: 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.
View official government recall

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