FDA-Device2021-03-31Class II
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.
Mizuho OSI
Hazard
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.
Sold states
Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.
Affected count
26 units
Manufactured in
30031 Ahern Ave, N/A, Union City, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1293-2021Don't want to check this manually?
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