FDA-Device2019-09-11Class II
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Heidelberg Engineering GmbH
Hazard
Error in the default configuration which could lead to the incorrect display of patient master data.
Sold states
US nationwide distribution
Affected count
29
Manufactured in
Tiergartenstr. 15, N/A, Heidelberg, N/A, Germany
Products
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2019Don't want to check this manually?
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