Z-2177-2013 Class II Terminated
FDA device recall Z-2177-2013 was initiated by Leica Microsystems (Schweiz) Ag on Dec 18, 2012 and is designated Class II. Reason for recall: The brake in the Z axis and/or brakes in the AB and C axes failed during installation. The recall status is terminated (terminated Apr 24, 2017). Affected quantity: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2013
- Initiation Date
- Dec 18, 2012
- Termination Date
- Apr 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
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.
Distribution Pattern
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