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U.S. Department of Health and Human Services

Class 2 Device Recall SonarMed AirWave

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  Class 2 Device Recall SonarMed AirWave see related information
Date Initiated by Firm December 22, 2021
Create Date January 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-0514-2022
Recall Event ID 89283
510(K)Number K193058  
Product Classification airway monitoring system - Product Code OQU
Product SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Code Information UDI-Device Identifier (GTIN/UPN): 00851334007001;  Serial Numbers: AW0501 AW0519 AW0537 AW0556 AW0502 AW0520 AW0540 AW0557 AW0503 AW0521 AW0541 AW0558 AW0504 AW0522 AW0542 AW0559 AW0505 AW0524 AW0543 AW0560 AW0506 AW0525 AW0544 AW0561 AW0507 AW0526 AW0545 AW0562 AW0508 AW0527 AW0546 AW0563 AW0509 AW0528 AW0548 AW0564 AW0510 AW0529 AW0549 AW0565 AW0511 AW0530 AW0550 AW0566 AW0512 AW0531 AW0551 AW0567 AW0513 AW0532 AW0552 AW0568 AW0514 AW0533 AW0553 AW0569 AW0515 AW0536 AW0554 AW0570 AW0516 AW0538 AW0555 AW0571 AW0517 AW0539
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall		 Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
FDA Determined
Cause 2		 Process control
Action Urgent Medical Device Recall were distributed to customers beginning 12/22/21. Actions you should take: " Immediately discontinue use of the affected SonarMed AirWave" monitors. Remove the affected devices listed on Attachment A from clinical service. " Notify all personnel in all care environments in which the affected SonarMed AirWave" monitors are used about this medical device recall. " If your facility has distributed affected SonarMed AirWave" monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. " Complete the attached Recalled Product Return Form even if you do not have inventory. " Customers are requested to return the item codes listed on Attachment A as described in this notice. Actions being taken by Medtronic: " Medtronic is implementing manufacturing process improvements to address the manufacturing assembly issue and is developing a software update to address the identified software anomaly. This software is projected to be available in Spring 2022 and will be factory installed on all newly manufactured SonarMed AirWave" monitors. Purchased directly from Medtronic: Customer with inventory: 1. Complete the Recalled Product Return Form and fax or email to Medtronic. 2. Ship affected product with Retuned Goods Authorization (RGA) number provided by Customer Service to: Medtronic Attn: Field Returns 195 McDermott Road North Haven, CT 06473. Customer with zero inventory: Complete form and check the box indicating no inventory and fax or email to Medtronic. Where to send the completed form: Fax to 800-895-6140 or email to rs.covidienfeedbackcustomerservice@medtronic.com Credit for returned affected product will be issued based on the RGA number. Exception: Customers with zero inventory, fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com Purchased from a distributor: Customer with inventory: 1. Complete the Recalled Product Return Form and fax or email to Medtron
Quantity in Commerce 66 devices
Distribution The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.
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.
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