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
- Recall Number
- Z-2176-2013
- Event Number
- 64601
- Firm
- Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland
- FEI Number
- 3003974370
- Product Code
- FSO
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 18, 2012
- Posted
- September 10, 2013
- Terminated
- April 24, 2017
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.
The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
The firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at [email protected] or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.
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.
5 units