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FDAFDA · Food and drugs·Recall number Z-2177-2013

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.

Published September 18, 2013 · Recall initiated: December 18, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Visit

Recall details

Manufacturer
Leica Microsystems (Schweiz) Ag
Distributor
Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.
Lot
Serial Numbers: OH5-45912, OH5-46012, OH5-46112, OH5-46212, OH5-46312, OH5-46412, OH5-46512, OH5-46612, OH5-46712, OH5-46912, OH5-47012, OH5-47112, OH5-47212, OH5-47312, OH5-47412, OH5-47512, OH5-47612, OH5-47812, OH5-47912, OH5-48012, OH5-48112, OH5-48212, OH5-48312, OH5-48312
Risk classification
Class II
Area (FDA)
device
Country
Switzerland

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