FDA Enforcement
Class II
Terminated
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.
Recall: Z-2176-2013
·
Reported September 18, 2013
Enforcement
- Recall Number
- Z-2176-2013
- Event ID
- 64601
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Leica Microsystems (Schweiz) Ag
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- September 18, 2013
- Initiation Date
- December 18, 2012
- Classification Date
- September 10, 2013
- Termination Date
- April 24, 2017
- Address
- 201 Max Schmidheiny-Strasse, N/A, Heerbrugg, N/A, N/A, Switzerland
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
The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
Code Info
Serial Numbers: OH4-84712, OH4-84812, OH4-84912
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.
Quantity
5 units