Home / Recalls / Medical Devices
Heidelberg Engineering recalls Widefield OCT software feature for the Spectralis HRA+OCT and variants
Recalled May 2, 2018 · FDA recall Z-1535-2018 · Heidelberg Engineering
Hazard
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. · FDA Class II
Units
382
Sold at
Nationally
Description
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.
Product
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Manufacturer(s)
Heidelberg Engineering
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →