Recall Z-0567-2021— Mizuho America, Inc.

Name: FDA recall Z-0567-2021
Creator: U.S. Food and Drug Administration
Published: 2019-09-11

Class II · Ongoing

Class II FDA medical device recall by Mizuho America, Inc., initiated 2019-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Microsurgical Operating Room Tables;7300BX (18-351-70).. Reason: Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX..

Recalling firm: Mizuho America, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-09-11
Firm location: Union City, CA, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.