Reported Sep 11, 2019 · Terminated
HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made…
Haag-Streit USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Haag-Streit USA Inc · 3535 Kings Mills Rd · Mason, OH · 45040-2303
Is this the product you have?
- HS Hi-R NEO 900A Reference # 657 821 Serial #
- from 101 Product UsageA 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
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx 2 Product: FS 2-21, Reference # 615 510, serial # from 361 3 Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx 4 Product: FS 2-25, Reference # 615 550, Serial # from 377 5 Product: FS 3-45, Reference # 615 705, Serial #from 101 - Amount recalled
- 0
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
software error in the central control unit of the floor stand.
This product could cause temporary or reversible health problems — stop using it.
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