Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic Recalled by Heidelberg Engineering GmbH Due to Error in the default configuration which could lead...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Heidelberg Engineering GmbH directly.
Affected Products
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Quantity: 29
Why Was This Recalled?
Error in the default configuration which could lead to the incorrect display of patient master data.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Heidelberg Engineering GmbH
Heidelberg Engineering GmbH has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report