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Heidelberg Engineering Recalls
2 recalls on record · May 2, 2018 to September 11, 2019 · Medical Devices
Recalls by year
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 11, 2019Medical DevicesFDA
Heidelberg Engineering GmbH recalls SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Hazard: Error in the default configuration which could lead to the incorrect display of patient master data.
May 2, 2018Medical DevicesFDA
Heidelberg Engineering recalls Widefield OCT software feature for the Spectralis HRA+OCT and variants
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.