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Leica Microsystems, Inc. recalls Leica ARveo and M530 OH6 microscope systems.
Recalled June 24, 2020 · FDA recall Z-2399-2020 · Leica Microsystems
Hazard
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage. · FDA Class II
Units
Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.
Sold at
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
Description
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
Product
Leica ARveo and M530 OH6 microscope systems.
Manufacturer(s)
Leica Microsystems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →