FDAJuly 3, 2019device
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Error in the default configuration which could lead to the incorrect display of patient master data.
What to do
FDA enforcement status: Terminated
Brands named
heidelberg engineeringheidelberg
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADraco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z2019-05-08
- FDADraco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neu...2018-12-14
- FDANeuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.2018-09-04
- FDADraco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z2018-03-21
- FDAFirst Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-42018-03-21
- FDAFirst Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-32018-03-21
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