Devices

Device Recall Leica M822 Surgical Microscope

Model / Serial
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
Product Classification
Ear, Nose, and Throat Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Leica Microsystems, Inc.
1 Event
- Recall of Device Recall Leica M822 Surgical Microscope

Manufacturer

Leica Microsystems, Inc.

Manufacturer Address
Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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