BEUDAMED
    FDA Recall Terminated

    9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

    Recall: Z-2744-2017 · Initiated April 13, 2017

    Recall

    Recall Number
    Z-2744-2017
    Event Number
    77137
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    GCW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 13, 2017
    Terminated
    March 22, 2019
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

    Reason

    Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.

    Action

    Pentax notified their customers on 4/13/2017 via USPS.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    241 units in total