Class 1 Device Recall SonarMed Air Wave

• Date Initiated by Firm: March 25, 2024
• Date Posted: April 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1535-2024
• Recall Event ID: 94302
• 510(K)Number: K193058
• Product Classification: airway monitoring system - Product Code OQU
• Product: AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
• Code Information: 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.
• Recalling Firm/ Manufacturer: SonarMed Inc; 12220 N Meridian St Ste 150; Carmel IN 46032-6972
• For Additional Information Contact: Technical Support; 800-255-6774
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: An Urgent Medical Device Recall notification dated 3/25/2024 was mailed to consignees via UPD notifying them of this SonarMed Sensor and Monitor recall. Consignees were asked to discontinue use of affected devices, quarantine any affected devices, and return all quarantined devices to Medtronic by obtaining a Returned Goods Authorization (RGA) from rs.covidienfeedbackcustomerservice@medtronic.com. If product was purchased through a distributor the distributor can arrange for return. The provided notification is to be provided to those within consignee organizations that need to be made aware and if product was further distributed. Consignees with questions are to contact customer service at 800-962-9888, Option 2.
• Quantity in Commerce: 145 units
• Distribution: _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OQU and Original Applicant = SonarMed, Inc.