The Recall Desk

FDA (Devices) recall action 64601

Leica Microsystems (Schweiz) Ag recalled 2 products on 2013-09-18

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-09-18
Critical
0
Units
33

Why these products were recalled

The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

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

1–2 of 2

  • HighFDA (Devices)··2013-09-18

    Leica Surgical Microscope Recall Due to Axis Brake Failure

    Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.

    Product
    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2013-09-18

    Leica Surgical Microscope Recall Due to Brake Failure During Installation

    Leica Microsystems is recalling five surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.

    Product
    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
    Category
    Distribution
    5 states