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Recall Observatory FDA recall evidence

Device product

Microsurgical Operating Room Tables;7300B (18-350-70);

Z-0566-2021

September 11, 2019

Class II

Product summary

Firm
Mizuho America, Inc.
Event
Event 85442
Status
Ongoing
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-0566-2021

Official wording

Reason: Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.