FDA Device Recall Z-1535-2024

SonarMed Inc · Carmel, IN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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.

Quantity: 145 units

Reason for recall

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

Recall record

Recall number: Z-1535-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_
Recall initiated: 2024-03-25
Classified by FDA Center: 2024-04-18
FDA published: 2024-04-24
Recalling firm: SonarMed Inc
Firm location: Carmel, IN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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