Surgical microscope The device is used to improve the visibility of objects through magnificat...
FDA Recall #Z-2177-2013 — Class II — December 18, 2012
Product Description
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.
Reason for Recall
The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
Recalling Firm
Leica Microsystems (Schweiz) Ag — Heerbrugg, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
28 units
Distribution
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.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated