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

Recall date

December 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1535-2018

FDA classification

Class II

Brand / firm

Heidelberg Engineering

Sold / distributed

Nationally

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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