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Recall Observatory FDA recall evidence

Device product

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

Z-0567-2021

September 11, 2019

Class II

Product summary

Firm
Mizuho America, Inc.
Event
Event 85442
Status
Ongoing
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-0567-2021

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: 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.

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.