FDA recall Z-0567-2021

Mizuho America, Inc. · Class II · device

Product

Microsurgical Operating Room Tables;7300BX (18-351-70).

Reason for recall

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

Distribution

US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.

Key facts

Status
Ongoing
Initiation date
2019-09-11
Report date
2020-12-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Union City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0567-2021