Recall Z-2483-2019— Haag-Streit USA Inc
Class II · Terminated
Class II FDA medical device recall by Haag-Streit USA Inc, initiated 2019-07-31, terminated 2020-04-16. FDA's recall record names no specific 510(k) clearance for this event. 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: software error in the central control unit of the floor stand..
- Recalling firm
- Haag-Streit USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-31
- Terminated
- 2020-04-16
- Firm location
- Mason, OH, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.