Z-2450-2019Class II

SonarMed AirWave Monitor, Model Number M0001

Name: Z-2450-2019 SonarMed AirWave Monitor, Model Number M0001
Creator: SonarMed Inc
Published: 2017-04-17
License: https://open.fda.gov/license/

Sonarmed, Inc. / initiated 2017-04-17 / Terminated / root cause: software

FDA source

SonarMed Inc began a recall of SonarMed AirWave Monitor, Model Number M0001 on 2017-04-17. FDA classified it as Class II and gives the reason as "Potential for the presence of two error codes which would make the monitor inoperable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2450-2019
Classification: Class II
Status: Terminated
Initiated: 2017-04-17
Posted: 2019-09-04
Terminated: 2020-07-16
Recalling firm: Sonarmed, Inc.
Product: SonarMed AirWave Monitor, Model Number M0001
Product code: OQU Airway Monitoring System
Reason for recall: Potential for the presence of two error codes which would make the monitor inoperable.
Root cause tag: software
FDA root cause: Software design
Action: April 2017, firm notifications were made in person at the time of the visit to upgrade the firmware. All monitors that had not been distributed were upgraded to the new firmware. All subsequent shipments will have the updated firmware.
Quantity in commerce: 16 units
Distribution: CA & TX
Product codes and lots: UDI Numbers: (01)00851334007001(11)130426(21)339 (01)00851334007001(11)130502(21)342 (01)00851334007001(11)131105(21)365 (01)00851334007001(11)140522(21)369 (01)00851334007001(11)140522(21)373 (01)00851334007001(11)150609(21)379 (01)00851334007001(11)150609(21)381 (01)00851334007001(11)150609(21)382 (01)00851334007001(11)150630(21)383 (01)00851334007001(11)150630(21)385 (01)00851334007001(11)150630(21)386 (01)00851334007001(11)150630(21)388 (01)00851334007001(11)150630(21)389 (01)00851334007001(11)150630(21)390 (01)00851334007001(11)150701(21)391 (01)00851334007001(11)150701(21)393

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2450-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2450-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-04

Product code OQU

K143042Class IISonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. / cleared 2016-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)