FDA Medical Device Recalls (openFDA)
Mizuho OSI: 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.
- Recall number
- Z-1293-2021
- Recalling firm
- Mizuho OSI
- 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.
- Status
- Open, Classified
- Initiated
- 2021-02-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 2/3/2021 Mizuho sent a "Recall Notice for Control Unit" notification letter to affected consignees via Email. In addition to informing consignees about the recall the notification asked consignees to take the following actions: 1. Identify if you have the affected product, 2. Mizuho will replace control units. As soon as we are ready for your institutions, Mizuho will supply the replacements. Please use the auxiliary switch on the operating table until the replacements arrive.
- Quantity
- 26 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDC
- Firm FEI
- 2921578
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28