FDANovember 20, 2020device
Haag 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
What to do
FDA enforcement status: Ongoing
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
- 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
- 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
- FDAEyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).2017-01-05
- FDAStreit's Quinoa with Mushrooms & Herbs, Net Wt. 7.7 oz (220g). Product of Israel2016-11-18
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