Heidelberg Engineering GmbH recalls SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
- Recall date
- July 3, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2437-2019
- FDA classification
- Class II
- Brand / firm
- Heidelberg Engineering GmbH
- Sold / distributed
- US nationwide distribution
Why it was recalled
Error in the default configuration which could lead to the incorrect display of patient master data.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
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