FDA recall Z-2450-2019
SonarMed Inc · Class II · device
Product
SonarMed AirWave Monitor, Model Number M0001
Reason for recall
Potential for the presence of two error codes which would make the monitor inoperable.
Distribution
CA & TX
Key facts
- Status
- Terminated
- Initiation date
- 2017-04-17
- Report date
- 2019-09-11
- Termination date
- 2020-07-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Carmel, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2019