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SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power… recallZ-0514-2022 · Covidien, LP · initiated Dec 22, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

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 [email protected] 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 [email protected] Purchased from a distributor: Customer with inventory: 1. Complete the Recalled Product Return Form and fax or email to Medtron

Recall details

Recall number
Z-0514-2022
Status
Open, Classified
Initiated by the company
Dec 22, 2021
Recalling firm
Covidien, LP
Quantity
66 devices
Product code
OQU
FDA submissions
K193058
Distribution
The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.

Product description

SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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