Medical device recalls Moderate risk

Leica Microsystems, Inc. recalls Leica ARveo and M530 OH6 microscope systems.

Recall date
May 20, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2399-2020
FDA classification
Class II
Brand / firm
Leica Microsystems, Inc.
Sold / distributed
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

Why it was recalled

Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Leica ARveo and M530 OH6 microscope systems.

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