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Haag-Streit USA Inc recalls HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are m
Recalled September 11, 2019 · FDA recall Z-2483-2019 · Haag-Streit USA
Hazard
software error in the central control unit of the floor stand. · FDA Class II
Units
0
Sold at
US in the state of OH
Description
software error in the central control unit of the floor stand.
Product
HS 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 ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
Manufacturer(s)
Haag-Streit USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →