FDAJanuary 5, 2017device
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
What to do
FDA enforcement status: Terminated
Brands named
haag streithaaghaag streit
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.42021-11-03
- FDAOCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.42021-11-03
- FDAEyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.2021-04-15
- FDAHaag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and...2020-11-20
- FDAHS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS...2019-07-31
- FDAHS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ...2019-07-31
- FDAHS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR an...2019-07-31
- FDAStreit's Quinoa with Mushrooms & Herbs, Net Wt. 7.7 oz (220g). Product of Israel2016-11-18
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