FDA Medical Device Recalls (openFDA)
Mizuho America, Inc.: Microsurgical Operating Room Tables;7300BX (18-351-70).
- Recall number
- Z-0567-2021
- Recalling firm
- Mizuho America, Inc.
- Product
- Microsurgical Operating Room Tables;7300BX (18-351-70).
- Status
- Open, Classified
- Initiated
- 2019-09-11
- Posted
- not on file
- Terminated
- not on file
- Reason
- Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.
- Root cause
- Device Design
- Action
- The firm's representatives notified their U.S. consignees regarding the recall notification by phone and a separate FedEx letter was sent (08/09/2019 - date the letter was issued). The Customer Notification Letter "IMPORTANT VOLUNTARY RECALL NOTIFICATION", informed customers of the two (2) types of errors: 1) Unintended Tilting of the Tabletop - Impurities in the hydraulic oil has caused minor leaking inside a control valve causing the table to tilt after remaining static for long periods of time. 2) Incorrect Operation due to Infrared Operating Signal Errors - The table can inadvertently mix infrared signals from the hand pendant while using in the wireless mode and may cause unintended movement. Customer are also being informed that a sales representative will contact them to organize the logistics of the correction for the tables. The recall notification includes to visit the firm's webpage (www.mizuho.com) to find additional information related to the recall. For additional questions, the Customer Service Group or local sales representatives can be contacted.
- Quantity
- 10
- Distribution
- US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.
- Lot, serial or model codes
- Tilt Movement-Leaking Valve (7300BX-18-351-70) serial numbers: MUC-20163-0001, MUC-2016Z-0002, MUC-2016Z-0003, MUC-20177-0005, MUC-20177-0007, MUC-20177-0008, MUC-20177-0009, MUC-20189-0017 & MUC-2018Y-0018. Unintended movement due to infrared signal errors (7300BX-18-351-70) serial numbers: MUC-20163-0001, MUC-2016Z-0002, MUC-2016Z-0003, MUC-20177-0005, MUC-20177-0007, MUC-20177-0008, MUC-20177-0009, MUC-20189-0017, MUC-2018Y-0018 & MUC-2018Y-0019.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDC
- Firm FEI
- 1000159388
- 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