Z-0567-2021Class II

Microsurgical Operating Room Tables;7300BX (18-351-70)

Name: Z-0567-2021 Microsurgical Operating Room Tables;7300BX (18-351-70)
Creator: Mizuho America, Inc.
Published: 2019-09-11
License: https://open.fda.gov/license/

Mizuho America, Inc. / initiated 2019-09-11 / Open, Classified / root cause: design

FDA source

Mizuho America, Inc. began a recall of Microsurgical Operating Room Tables;7300BX (18-351-70) on 2019-09-11. FDA classified it as Class II and gives the reason as "Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0567-2021
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-11
Posted: 2020-12-14
Recalling firm: Mizuho America, Inc.
Product: Microsurgical Operating Room Tables;7300BX (18-351-70).
Product code: GDC Table, Operating-Room, Electrical
Reason for recall: 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 tag: design
FDA 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 in commerce: 10
Distribution: US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0567-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0566-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-23	2020-12-14
Z-0567-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-23	2020-12-14

Product code GDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)