Z-0772-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 30, 2019
- Initiation Date
- January 2, 2019
- Termination Date
- April 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Reason for Recall
The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Albania, Algeria, Armenia, Argentina, Bangladesh, Brazil, Burundi, Canada, China, Colombia, Egypt, France, Germany, Guatemala, India, Indonesia, Japan, Nepal, Netherlands, New Zealand, Malaysia, Pakistan, Peru, Philippines, Poland, Qatar, Romania, Russia Federation, Saudi Arabia, Senegal, Spain, South Africa, South Korea, Switzerland, Tanzania, Thailand, Turkey, Ukraine, and Vietnam.
Code Information
Serial Numbers: 10448367-60618002, 10448367-150317002, 10448367-40518001, 10448367-170417002, 10448367-80517001, 10448367-131117001, 10448367-271117001, 10448367-91017002, 10448367-220318003, 10448367-61017001, 10448367-171117001, 10448367-90418001, 10448367-170417001, 10448367-20418001, 10448367-170718002