FDA recall Z-2483-2019

Haag-Streit USA Inc · Class II · device

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.

Reason for recall

software error in the central control unit of the floor stand.

Distribution

US in the state of OH

Key facts

Status
Terminated
Initiation date
2019-07-31
Report date
2019-09-11
Termination date
2020-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mason, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2483-2019