Recall Z-2176-2013 ยท FSO Microscope, Surgical, General & Plastic Surgery
Leica Microsystems (Schweiz) Ag
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.
| Date | Sep 10, 2013 (initiated Dec 18, 2012) |
| Status | Terminated |
| Reason | The brake in the Z axis and/or brakes in the AB and C axes failed during installation. |
| Root cause | Device Design |
| Action | 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 LMGRA@leica-microsystems.com 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 c |
| Quantity | 5 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.