FDA recall Z-1293-2021

Mizuho OSI · Class II · device

Product

Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

Reason for recall

There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.

Distribution

Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.

Key facts

Status
Ongoing
Initiation date
2021-02-08
Report date
2021-03-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Union City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1293-2021