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Open, Classified

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

FDA Recall Z-0567-2021 · Posted None

Recalling FirmMizuho America, Inc.
Recall StatusOpen, Classified
Product CodeGDC
Date Initiated2019-09-11
Product Quantity10

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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