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U.S. Department of Health and Human Services

Class 2 Device Recall Mizuho Microsurgical Operating Room Tables

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  Class 2 Device Recall Mizuho Microsurgical Operating Room Tables see related information
Date Initiated by Firm September 11, 2019
Create Date December 14, 2020
Recall Status1 Open3, Classified
Recall Number Z-0566-2021
Recall Event ID 85442
Product Classification Table, operating-room, electrical - Product Code GDC
Product Microsurgical Operating Room Tables;7300B (18-350-70);
Code Information MUC-20168-0001, MUC-20168-0002, MUC-20171-0003, MUC-20171-0004, MUC-20173-0005, MUC-20173-0006, MUC-20178-0007 & MUC-20178-0008
Recalling Firm/
Manufacturer		 Mizuho America, Inc.
30057 Ahern Ave
Union City CA 94587-1234
For Additional Information Contact
510-324-4500 Ext. 150
Manufacturer 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.
FDA Determined
Cause 2		 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 8
Distribution US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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