BEUDAMED
    FDA Enforcement Class I Ongoing

    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

    Recall: Z-1535-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1535-2024
    Event ID
    94302
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SonarMed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2024
    Initiation Date
    March 25, 2024
    Classification Date
    April 18, 2024
    Address
    12220 N Meridian St Ste 150, Carmel, IN, 46032-6972, United States

    Description

    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

    Reason

    Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.

    Code Info

    Model No. AW-M0001; GTIN: 00851334007001; Serial No. AW0572, AW0573, AW0574, AW0577, AW0578, AW0579, AW0580, AW0581, AW0584, AW0585, AW0586, AW0588, AW0591, AW0593, AW0594, AW0600, AW0606, AW0607, AW0615, AW0616, AW0624, AW0626, AW0627, AW0648, AW0650, AW0651, AW0658, AW0664, AW0672, AW0674, AW0675, AW0678, AW0680, AW0681, AW0684, AW0685, AW0701, AW0702, AW0703, AW0704, AW0705, AW0706, AW0707, AW0708, AW0709, AW0710, AW0711, AW0712, AW0718, AW0719, AW0720, AW0721, AW0722, AW0723, AW0724, AW0725, AW0726, AW0727, AW0728, AW0729, AW0730, AW0731, AW0732, AW0733, AW0734, AW0735, AW0736, AW0737, AW0738, AW0739, AW0740, AW0741, AW0742, AW0743, AW0744, AW0745, AW0746, AW0747, AW0748, AW0749, AW0763, AW0764, AW0765, AW0766, AW0767, AW0768, AW0769, AW0770, AW0771, AW0772, AW0773, AW0774, AW0775, AW0776, AW0777, AW0778, AW0779, AW0780, AW0781, AW0782, AW0783, AW0784, AW0785, AW0786, AW0787, AW0788, AW0789, AW0790, AW0791, AW0792, AW0793, AW0794, AW0795, AW0796, AW0797, AW0798, AW0799, AW0800, AW0804, AW0805, AW0814, AW0817, AW0818, AW0819, AW0820, AW0821, AW0825, AW0826, AW0827, AW0828, AW0830, AW0831, AW0832, AW0833, AW0834, AW0835, AW0836, AW0837, AW0838, AW0839, AW0840, AW0841, AW0842, AW0854, AW0855.

    Distribution

    _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_

    Quantity

    145 units