FDA Enforcement Class II Terminated

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.

Recall: Z-0772-2019 · Reported January 30, 2019

Enforcement

Recall Number
Z-0772-2019
Event ID
81903
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Leica Microsystems, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
January 30, 2019
Initiation Date
January 2, 2019
Classification Date
January 24, 2019
Termination Date
April 2, 2021
Address
1700 Leider Ln, N/A, Buffalo Grove, IL, 60089-6622, United States

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

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

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

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.

Quantity

15 units