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Device product

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.

Z-0772-2019

January 02, 2019

Class II

Product summary

Firm
Leica Microsystems, Inc.
Event
Event 81903
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-0772-2019

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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