FDA recall Z-2399-2020

Product

Leica ARveo and M530 OH6 microscope systems.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-05-20

Report date

2020-06-24

Termination date

2021-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2399-2020