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

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.

On December 14, 2017 an URGENT Medical device software field correction letter was issued to customers via email or ground mail to notify all customers of the recall action. The letter states the following: FDA has asked us to instruct you not to use the Widefield OCT feature on your SPECTRALIS device until a decision is made on this pending 510(k) submission. Heidelberg Engineering will notify you immediately upon completion of the FDAs review. In the meantime, you may continue to use your Widefield Objective for cSLO fundus imaging (including Fluorescein Angiography, ICG Angiography, MultiColor, Infrared and Red-Free Fundus Imaging). Questions or concerns can be directed to (508) 530-5904