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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