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.
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- January 2, 2019
- Terminated
- April 2, 2021
- Recall Number
- Z-0772-2019
- Quantity
- 15 units
- Firm Location
- Buffalo Grove, IL
Reason for Recall
The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
Distribution
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.
Lot / Code Info
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
Root Cause
Process control
Action Taken
The firm, Leica, disseminated an "URGENT FIELD SAFETY NOTICE" dated 12/18/2018 on 01/02/2019 to its customers. The notice described the product, problem and actions to be taken. The notice directed the user to inspect the device for a gap between the black adapter and the white housing or a free rotation of the optics carrier for more 360o. If either are noted, the device could not be used. If you have any questions, contact the Clinical & Scientific Affairs Specialist at 847-876-5705 or email to: Jason.Battle@leica-miosystems.com.