Reported Mar 31, 2021 · Ongoing

Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage:…

Mizuho OSI

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mizuho OSI · 30031 Ahern Ave · Union City, CA · 94587-1234

Is this the product you have?

    • Mizuho CE IPX4
    • mode MOT-5602BW
    • 100-240
    • 50-60Hz
    • 400VA
    • REF 18-140-20 containing
  • hand control Unit - Product Usageintended to support a patient during surgical operations
Lot codes and dates
  • S/N (Control
  • unit) - S/N (Operating table)
    • 10290134 - MEC-20195-0034
    • 10290135 - MEC-20195-0036
    • 10290136 - MEC-20195-0035
    • 10290137 - MEC-20195-0033
    • 10490143 - MEC-20198-0038
    • 10490144 - MEC-20198-0037
    • 10490145 - MEC-20198-0040
    • 10490147 - MEC-20198-0039
    • 10690148 - MEC-2019Y-0054
    • 10690149 - MEC-20199-0049
    • 10690150 - MEC-2019Y-0059
    • 10690153 - MEC-2019Y-0058
    • 10690154 - MEC-20199-0046
    • 10690155 - MEC-2019Y-0057
    • 10690156 - MEC-20199-0050
    • 10690157 - MEC-20199-0044
    • 10690159 - MEC-20199-0047
    • 10690160 - MEC-20199-0051
    • 10690161 - MEC-20199-0045
    • 10690162 - MEC-20199-0048
    • 10690163 - MEC-2019Y-0053
    • 10790167 - MEC-2019Y-0052
    • 10790169 - MEC-2019Y-0056
    • 10790170 - MEC-2019Y-0055
    • 211080129 - MEC-2018Z-0029
    • 11080130 - MEC-2018Z-0028
Amount recalled
26 units

Where it was sold

  • Nationwide
  • CA

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.