Device evidence

device-recall:cfres:175755

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.

Official recall number

Z-2483-2019

Evidence summary

Product code: EPT
Recall status: Terminated
Event initiated: July 31, 2019
Root cause: Software Manufacturing/Software Deployment
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-2483-2019