The Recall Desk

FDA (Devices) recall action 83571

Haag-Streit USA Inc recalled 3 products on 2019-09-11

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-09-11
Critical
0
Units
1

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900 Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900 operating microscopes because a software error in the floor stand's central control unit may affect device function.

    Product
    HS Hi-R NEO 900 Reference # 657 820 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 H
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-09-11

    Haag-Streit Operating Microscope Floor Stand Software Error Recall

    Haag-Streit USA Inc is recalling specific operating microscope floor stands due to a software error in the central control unit.

    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 H
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900A Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A NIR Reference # 657 822 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/
    Category
    Distribution
    1 state