FDA-Device2020-06-24Class II
Leica ARveo and M530 OH6 microscope systems.
Leica Microsystems, Inc.
Hazard
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
Sold states
Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan
Affected count
Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.
Manufactured in
1700 Leider Ln, Buffalo Grove, IL, United States
Products
Leica ARveo and M530 OH6 microscope systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2399-2020Don't want to check this manually?
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