SonarMed AirWave Monitor, Model Number M0001 recallZ-2450-2019 · SonarMed Inc · initiated Apr 17, 2017
Terminated
Is my device affected?
- 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.
- If yours is listed, follow the instructions from SonarMed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Potential for the presence of two error codes which would make the monitor inoperable.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2450-2019
- Status
- Terminated
- Initiated by the company
- Apr 17, 2017
- Recalling firm
- SonarMed Inc
- Quantity
- 16 units
- Product code
- OQU
- FDA submissions
- K143042
- Distribution
- CA & TX
Product description
SonarMed AirWave Monitor, Model Number M0001
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SonarMed AirWave AW-M0001Sonarmed, Inc · Airway Monitoring System3 recalls2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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