BEUDAMED
    FDA Enforcement Class II 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 · Reported July 26, 2017

    Enforcement

    Recall Number
    Z-2744-2017
    Event ID
    77137
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2017
    Initiation Date
    April 13, 2017
    Classification Date
    July 18, 2017
    Termination Date
    March 22, 2019
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    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.

    Code Info

    35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    241 units in total