Device Recall Leica M822 Surgical Microscope

Article 10448446, serial numbers 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004. The corrected units will have controller software version MDC V3.6 pack G

Ear, Nose, and Throat Devices

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No

Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey.

Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland || The intended use of the microscope is 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.