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Heidelberg Engineering GmbH recalls SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Recalled September 11, 2019 · FDA recall Z-2437-2019 · Heidelberg Engineering
Hazard
Error in the default configuration which could lead to the incorrect display of patient master data. · FDA Class II
Units
29
Sold at
US nationwide distribution
Description
Error in the default configuration which could lead to the incorrect display of patient master data.
Product
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Manufacturer(s)
Heidelberg Engineering GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →