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Terminated

SonarMed AirWave Monitor, Model Number M0001

FDA Recall Z-2450-2019 · Posted None

Recalling FirmSonarMed Inc
Recall StatusTerminated
Product CodeOQU
Date Initiated2017-04-17
Date Terminated2020-07-16
Product Quantity16 units

Reason for Recall

Potential for the presence of two error codes which would make the monitor inoperable.

Firm 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.

Root Cause

Software design

Distribution Pattern

CA & TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016-01-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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